Clinical trial • Phase III • Oncology|Gastroenterology

CALCIUM FOLINATE PENTAHYDRATE for Metastatic colorectal cancer

Phase III trial of CALCIUM FOLINATE PENTAHYDRATE for Metastatic colorectal cancer.

Overview

Trial Therapeutic Area
Oncology|Gastroenterology
Trial Disease
Metastatic colorectal cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-10-2024
First CTIS Authorization Date
13-11-2024

Trial design

Randomised, open-label, active post-resection/ablation chemotherapy versus structured follow-up only. active arm: additive chemotherapy after definitive treatment of metastases (regimens referenced in protocol include oxaliplatin-, irinotecan- and fluoropyrimidine-based regimens such as folfox, capox, folfiri/folfoxiri as applicable). control arm: structured follow-up only. Phase III trial across 67 sites in Germany.

Randomised
Yes
Open Label
Yes
Comparator
Active post-resection/ablation chemotherapy versus structured follow-up only. Active arm: additive chemotherapy after definitive treatment of metastases (regimens referenced in protocol include oxaliplatin-, irinotecan- and fluoropyrimidine-based regimens such as FOLFOX, CAPOX, FOLFIRI/FOLFOXIRI as applicable). Control arm: structured follow-up only.
Target Sample Size
507
Trial Duration For Participant
730

Eligibility

Recruits 507 Vulnerable population flag selected. Only adults (age ≥18) are eligible and the criteria require the patient’s signed informed consent. Individuals with limited legal capacity are explicitly excluded. Consent must therefore be provided by the participant themselves; there is no mention of assent procedures for minors (minors excluded)..

Pregnancy Exclusion
Pregnant or breastfeeding females.
Vulnerable Population
Vulnerable population flag selected. Only adults (age ≥18) are eligible and the criteria require the patient’s signed informed consent. Individuals with limited legal capacity are explicitly excluded. Consent must therefore be provided by the participant themselves; there is no mention of assent procedures for minors (minors excluded).

Inclusion criteria

  • {"criterion_text":"- Patient’s signed informed consent.\n- Proficient fluorouracil metabolism as defined: a) Prior treatment with 5-FU or capecitabine without unusual toxicity or b) If tested, normal DPD deficiency test according to the standard of the study site or c) If tested, in patients with DPD deficiency test with a CPIC activity score of 1.0-1.5 fluoropyrimidine/capecitabine dosage should be reduced by 50%\n- For women of childbearing potential (WOCBP): negative pregnancy test within 14 days before randomization and agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 9 months after the last dose of Oxaliplatin or for at least 6 months after the last dose of all other study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male partner’s sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. For men: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of study treatment. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 6 months after the last dose of study medication to avoid exposing the embryo.\n- Patient’s age ≥18 years at the time of signing the informed consent\n- Histologically confirmed adenocarcinoma of the colon or rectum\n- Resected (R0 or R1) and/or effectively treated metastases (all techniques allowed) of colorectal cancer within 3-10 weeks before randomization (earlier randomisation allowed if at least 3 weeks interval between intervention and treatment start is guaranteed) AND resected primary tumor (synchronous or metachronous). In cases of synchronous metastases the interval of 3-10 weeks might be calculated following the removal of the primary tumor if this intervention was the last to address all tumor lesions\n- Absence of significant active wound healing complications (if applicable) at randomization. Resolved wound healing complications after resection/ablation are acceptable for inclusion into the trial\n- No radiographic evidence of active metastatic disease at study entry in a CT and/or MRI scan not older than 10 weeks prior randomization. Pre- surgery/ablation images are eligible for the study if all lesions have been addressed in the interval\n- ECOG performance status 0-2.\n- Adequate bone marrow, hepatic and renal organ function, defined by the following laboratory test results: • Absolute neutrophil count 1.5 x 109/L (1500/µL) • Hemoglobin ≥ 80 g/L (8 g/dL) • Platelet count ≥ 100 x109/L (100000/µL) without transfusion • Total serum bilirubin of ≤ 1.5 x upper limit of normal (ULN) • Aspartate aminotransferase (AST/GOT) ≤ 3.0 × ULN. • Calculated glomerular filtration rate (GFR) according to Cockcroft-Gault formula or according to MDRD ≥ 50 mL/min or serum creatinine ≤ 1.5 x ULN\n- Patients without anticoagulation need to present with an INR < 1.5 x ULN and PTT < 1.5 x ULN. Patient with prophylactic or therapeutic anticoagulation are allowed into the trial."}

Exclusion criteria

  • {"criterion_text":"- Treatment of metastases greater than 3 cm with radio-frequency/microwave ablation within 24 months prior to study entry if applicable.\n- Severe chronic non-healing wounds, ulcerous lesions or untreated bone fracture.\n- Known hypersensitivity to 5-FU, folinic acid irinotecan, oxaliplatin or capecitabine or to any of the other excipients listed in section 6.1 of the corresponding SmPC.\n- Recent or concomitant treatment with brivudine.\n- Peripheral sensitive neuropathy with functional impairment (> grade 1 acc. to CTCAE version 5.0 (see appendix 2)).\n- Inflammatory bowel disease and/or bowel obstruction.\n- Simultaneous application of Johannis herbs preparations.\n- Pernicious or other megaloblastic anaemia caused by vitamin B12 deficiency.\n- Major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to randomization or at least to intended treatment start or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure.\n- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.\n- Medical history of malignant disease other than mCRC with the following exceptions: -\tpatients who have been disease-free for at least three years before randomization -\tpatients with adequately treated and completely resected basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer, stage I uterine cancer -\tpatients with any treated or untreated malignant disease that is associated with a 5-year survival prognosis of ≥ 90% and does not require active therapy\n- Treatment of metastases greater than 5 cm with radiation (stereotactic/ brachytherapy) within 24 months prior to study entry if applicable.\n- Known alcohol or drug abuse.\n- Pregnant or breastfeeding females.\n- Participation in a clinical trial or experimental drug treatment within 28 days prior to potential inclusion in the clinical trial or within a period of 5 half-lives of the substances administered in a clinical trial or during an experimental drug treatment prior to potential inclusion in the clinical trial, depending on which period is longest, or simultaneous participation in another clinical trial while taking part in this clinical trial.\n- Patients depended on Sponsor, investigator or study site.\n- Suspected SARS-CoV-2 infection with or without symptoms (evaluation according to local policy in respective center with respect to actual status of pandemic and with reference to the policy that would apply to patients with similar therapy outside the trial). This may include assessment of vaccination status, anamnesis, physical examination and potentially antigen and/or PCR testing.\n- Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.\n- Limited legal capacity.\n- Concomitant administration of strong CYP3A4 and/or UGT1A1 inducers (e.g. Rifampicin, Carbamazepin, Phenobarbital, Phenytoin or Apalutamid).\n- Planned inoculation/vaccination with a live vaccine during treatment with Oxaliplatin and/or Irinotecan, and until 6 months after treatment with Irinotecan\n- Any previous systemic therapy is allowed for inclusion into the trial. However, if previous oxaliplatin-containing chemotherapy at any time for metastatic or localized disease was carried out, the inclusion into the trial is permitted under the condition, that a)\tA total duration of oxaliplatin-based therapy of six months (i.e. 12 cycles of FOLFOX / FOLFOXIRI or 8 cycles CAPOX) is not exceeded - including therapy within the FIRE-9/PORT trial b)\tIf already more than three months of oxaliplatin-based therapy (i.e. >6 cycles of FOLFOX / FOLFOXIRI or >4 cycles CAPOX) was used, the study therapy should be started with an irinotecan-based regimen (i.e. FOLFIRI or FOLFOXIRI) However, in the case of FOLFOXIRI therapy in the trial, the above mention regulation concerning the total dosing of oxaliplatin still applies (i.e. 12 cycles of FOLFOX / FOLFOXIRI or 8 cycles CAPOX should not be exceeded - including therapy within the FIRE-9/PORT trial).\n- New York Heart Association Class III or greater heart failure by clinical judgement.\n- Myocardial infarction within 6 months prior to randomization; percutaneous transluminal coronary angioplasty (PTCA) with or without stenting within 6 months prior to randomization.\n- Unstable angina pectoris.\n- Unstable cardiac arrhythmia > grade 2 NCI CTCAE despite anti-arrhythmic therapy.\n- Ongoing toxicities > grade 2 NCI CTCAE\n- Active uncontrolled infection by investigator’s perspective."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) time at the 24 months follow-up defined as time from randomization to death or evidence of disease (whatever occurs first)","definition_or_measurement_approach":"PFS at 24 months follow-up defined as time from randomization to death or radiographic/clinical evidence of disease (whichever occurs first); assessed up to 24 months after randomization."}

Recruitment

Planned Sample Size
507
Recruitment Window Months
109
Consent Approach
Informed consent must be signed by the patient ("Patient’s signed informed consent"). Only adults (≥18 years) are eligible; limited legal capacity is an exclusion. No details on assent or multiple-language documents are available in the provided data.

Geography

Total Number Of Sites
67
Total Number Of Participants
507

Germany

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
04-09-2025
Processing Time Days
315
Number Of Sites
67
Number Of Participants
507

Sites

Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medizinische Klinik I
Principal Investigator Name
Gunnar Folprecht
Principal Investigator Email
gunnar.folprecht@uniklinikum-dresden.de
Contact Person Name
Gunnar Folprecht
Site Name
Petrus-Krankenhaus
Department Name
Klinik für Innere Medizin III
Principal Investigator Name
Matthias Sandmann
Principal Investigator Email
Matthias.Sandmann@cellitinnen.de
Contact Person Name
Matthias Sandmann
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Hämatologie und Onkologie
Principal Investigator Name
Dominik Modest
Principal Investigator Email
dominik.modest@charite.de
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de
Site Name
Rheinland Klinikum Neuss GmbH
Department Name
Lukaskrankenhaus Neuss Medizinische Klinik II
Principal Investigator Name
Ulf Reinhart
Principal Investigator Email
ulf.reinhart@rheinlandklinikum.de
Contact Person Name
Ulf Reinhart
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
Principal Investigator Name
Dominik Modest
Principal Investigator Email
dominik.modest@charite.de
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik für Allgemeine Chirugie, Viszeral-, Gefäß- und Kinderchirurgie
Principal Investigator Name
Matthias Glanemann
Principal Investigator Email
matthias.glanemann@uks.eu
Contact Person Name
Matthias Glanemann
Contact Person Email
matthias.glanemann@uks.eu
Site Name
Dr. Vehling-Kaiser MVZ GmbH
Department Name
VK & K Studien GbR
Principal Investigator Name
Florian Kaiser
Principal Investigator Email
dr.f.kaiser@vehling-kaiser.de
Contact Person Name
Florian Kaiser
Contact Person Email
dr.f.kaiser@vehling-kaiser.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Allgemein-, Viszeral- und Kinderchirurgie
Principal Investigator Name
Peter Jo
Principal Investigator Email
peter.jo@med.uni-goettingen.de
Contact Person Name
Peter Jo
Contact Person Email
peter.jo@med.uni-goettingen.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Med. Klinik und Poliklinik III
Principal Investigator Name
Victoria Probst
Principal Investigator Email
victoria.probst@med.uni-muenchen.de
Contact Person Name
Victoria Probst
Site Name
Franziskus Hospital Harderberg
Department Name
Niels-Stensen-Kliniken
Principal Investigator Name
Jens Atzpodien
Principal Investigator Email
jens.atzpodien@niels-stensen-kliniken.de
Contact Person Name
Jens Atzpodien
Site Name
Muenchen Klinik gGmbH
Department Name
Klinik für Gastroenterologie, Hepatologie und gastroenterologische Onkologie
Principal Investigator Name
Martin Fuchs
Principal Investigator Email
martin.fuchs@muenchen-klinik.de
Contact Person Name
Martin Fuchs
Site Name
Staedtisches Klinikum Dessau
Department Name
Klinik für Innere Medizin I
Principal Investigator Name
Gerhard Behre
Principal Investigator Email
gerhard.behre@klinikum-dessau.de
Contact Person Name
Gerhard Behre
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Gastroenterologie, Hepatologie und Infektiologie
Principal Investigator Name
Christoph Roderburg
Contact Person Name
Christoph Roderburg
Site Name
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
Department Name
Gemeinschaftspraxis für Hämatologie und Onkologie
Principal Investigator Name
Christian Lerchenmüller
Principal Investigator Email
lerchenmueller@onkologie-muenster.de
Contact Person Name
Christian Lerchenmüller
Site Name
Lahn-Dill-Kliniken GmbH
Department Name
Klinik für Hämatologie/Onkologie und Palliativmedizin
Principal Investigator Name
Birgitta Killing
Principal Investigator Email
Birgitta.Killing@lahn-dill-kliniken.de
Contact Person Name
Birgitta Killing
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für internistische Onkologie/Hämatologie
Principal Investigator Name
Christian Müller
Principal Investigator Email
ch.mueller@kem-med.com
Contact Person Name
Christian Müller
Contact Person Email
ch.mueller@kem-med.com
Site Name
Romed Klinikum Rosenheim
Department Name
Onkologische Tagesklinik
Principal Investigator Name
Gerhard Puchtler
Principal Investigator Email
gerhard.puchtler@ro-med.de
Contact Person Name
Gerhard Puchtler
Contact Person Email
gerhard.puchtler@ro-med.de
Site Name
Klinikum Bayreuth GmbH
Department Name
Medizinische Klinik IV
Principal Investigator Name
Alexander Kiani
Principal Investigator Email
alexander.kiani@klinikum-bayreuth.de
Contact Person Name
Alexander Kiani
Site Name
Universitaet Leipzig
Department Name
Universitäres Krebszentrum Leipzig (UCCL)
Principal Investigator Name
Ulrich Hacker
Principal Investigator Email
ulrich.hacker@medizin.uni-leipzig.de
Contact Person Name
Ulrich Hacker
Site Name
Universitaet Muenster
Department Name
Medizinische Klinik A
Principal Investigator Name
Klaus Wethmar
Principal Investigator Email
Klaus.wethmar@ukmuenster.de
Contact Person Name
Klaus Wethmar
Contact Person Email
Klaus.wethmar@ukmuenster.de
Site Name
FEK Friedrich-Ebert-Krankenhaus Neumuenster GmbH
Department Name
Klinik für Hämatologie, Onkologie und Nephrologie
Principal Investigator Name
Siegfried Haas
Principal Investigator Email
Siegfried.haas@fek.de
Contact Person Name
Siegfried Haas
Contact Person Email
Siegfried.haas@fek.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Innere Klinik (Tumorforschung)
Principal Investigator Name
Stefan Kaspar-Virchow
Principal Investigator Email
stefan.kasper@uk-essen.de
Contact Person Name
Stefan Kaspar-Virchow
Contact Person Email
stefan.kasper@uk-essen.de
Site Name
Gemeinschaftspraxis für Hämatologie und Internistische Onkologie am Klinikum Fürth
Department Name
Hämatologie und Internistische Onkologie
Principal Investigator Name
Jochen Wilke
Principal Investigator Email
jw-studies@hotmail.de
Contact Person Name
Jochen Wilke
Contact Person Email
jw-studies@hotmail.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. Medizinische Klinik und Poliklinik
Principal Investigator Name
Markus Möhler
Principal Investigator Email
Markus.moehler@unimedizin-mainz.de
Contact Person Name
Markus Möhler
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Med. Klinik m. S. Hämatologie, Onkologie u. Tumorimmunologie
Principal Investigator Name
Dominik Modest
Principal Investigator Email
dominik.modest@charite.de
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de
Site Name
Onkologischer Schwerpunkt Am Oskar Helene Heim MVZ
Department Name
Medizinisches Versorgungszentrum Onkologischer Schwerpunkt am Oskar-Helene-Heim
Principal Investigator Name
Markus Schuler
Principal Investigator Email
Markus.Schuler@onkologie-ohh.de
Contact Person Name
Markus Schuler
Site Name
HELIOS Klinikum Emil von Behring GmbH
Department Name
Klinik für Hämatologie und Onkologie
Principal Investigator Name
Börge Arndt
Principal Investigator Email
Boerge.Arndt@helios-gesundheit.de
Contact Person Name
Börge Arndt
Site Name
Haematologisch Onkologische Schwerpunktpraxis
Department Name
Gemeinschaftspraxis
Principal Investigator Name
Björn Schöttker
Principal Investigator Email
b.schoettker@onkopraxis-wuerzburg.de
Contact Person Name
Björn Schöttker
Site Name
Klinikum Leverkusen gGmbH
Department Name
Medizinische Klinik 3
Principal Investigator Name
Andrea Heider
Principal Investigator Email
andrea.heider@klinikum-lev.de
Contact Person Name
Andrea Heider
Contact Person Email
andrea.heider@klinikum-lev.de
Site Name
Klinikum Nuernberg
Department Name
5. Medizinische Klinik Onkologie/Hämatologie
Principal Investigator Name
Gabriele Siegler
Principal Investigator Email
Gabriele.Siegler@klinikum-nuernberg.de
Contact Person Name
Gabriele Siegler
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik 1
Principal Investigator Name
Christine Koch
Principal Investigator Email
christine.koch@unimedizin-ffm.de
Contact Person Name
Christine Koch
Site Name
Muenchen Klinik gGmbH
Department Name
München Klinik Neuperlach Klinik für Hämatologie und Onkologie
Principal Investigator Name
Michael Haas
Principal Investigator Email
Michael.Haas@muenchen-klinik.de
Contact Person Name
Michael Haas
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Hämatologie und Onkologie
Principal Investigator Name
Annette Dieing
Principal Investigator Email
klinische.forschung@vivantes.de
Contact Person Name
Annette Dieing
Site Name
Klinikum St Marien Amberg
Department Name
Studienzentrum
Principal Investigator Name
Ludwig Fischer von Weikersthal
Principal Investigator Email
weikersthal.ludwig@klinikum-amberg.de
Contact Person Name
Ludwig Fischer von Weikersthal
Site Name
DIAK Klinikum Schwäbisch Hall
Department Name
Klinik für Innere Medizin III
Principal Investigator Name
Thomas Geer
Principal Investigator Email
Thomas.Geer@diakoneo.de
Contact Person Name
Thomas Geer
Contact Person Email
Thomas.Geer@diakoneo.de
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Department Name
BAG Onkologische Gemeinschaftspraxis
Principal Investigator Name
Lutz Jacobasch
Principal Investigator Email
jacobasch@onkologie-dresden.net
Contact Person Name
Lutz Jacobasch
Site Name
Medical Center - University Of Freiburg
Department Name
Medizinische Klinik II
Principal Investigator Name
Michael Quante
Principal Investigator Email
michael.quante@uniklinik-freiburg.de
Contact Person Name
Michael Quante
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Universitätsklinik und Poliklinik für Innere Medizin IV
Principal Investigator Name
Franziska Jahn
Principal Investigator Email
franziska.jahn@uk-halle.de
Contact Person Name
Franziska Jahn
Contact Person Email
franziska.jahn@uk-halle.de
Site Name
Philipps-Universitaet Marburg
Department Name
Klinik für Innere Medizin
Principal Investigator Name
Jorge Riera Knorrenschild
Principal Investigator Email
rierakno@med.uni-marburg.de
Contact Person Name
Jorge Riera Knorrenschild
Contact Person Email
rierakno@med.uni-marburg.de
Site Name
Studienzentrum Onkologie Ravensburg GmbH
Department Name
Onkologie
Principal Investigator Name
Tobias Dechow
Principal Investigator Email
dechow@onkonet.eu
Contact Person Name
Tobias Dechow
Contact Person Email
dechow@onkonet.eu
Site Name
MVM Medizinische Verwaltungs und Managementgesellschaft mbH
Department Name
Studienzentrum UnterEms
Principal Investigator Name
Lothar Müller
Principal Investigator Email
Lothar.mueller@onkologie-ue.de
Contact Person Name
Lothar Müller
Contact Person Email
Lothar.mueller@onkologie-ue.de
Site Name
HELIOS Klinikum Bad Saarow GmbH
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Daniel Pink
Principal Investigator Email
Daniel.Pink@helios-gesundheit.de
Contact Person Name
Daniel Pink
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung am Krankenhaus Nordwest
Principal Investigator Name
Thorsten Götze
Principal Investigator Email
Goetze.thorsten@khnw.de
Contact Person Name
Thorsten Götze
Contact Person Email
Goetze.thorsten@khnw.de
Site Name
Rostock University Medical Center
Department Name
Klinik III (Hämatologie, Onkologie, Palliativmedizin)
Principal Investigator Name
Ulrich Langenkamp
Principal Investigator Email
ulrich.langenkamp@med.uni-rostock.de
Contact Person Name
Ulrich Langenkamp
Site Name
Klinikum Passau Service GmbH
Department Name
II. Medizinische Klinik
Principal Investigator Name
Thomas Südhoff
Principal Investigator Email
thomas.suedhoff@klinikum-passau.de
Contact Person Name
Thomas Südhoff
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin I
Principal Investigator Name
Thomas Ettrich
Principal Investigator Email
thomas.ettrich@uniklinik-ulm.de
Contact Person Name
Thomas Ettrich
Site Name
Barmherzige Brueder Trier gGmbH
Department Name
I. Medizinische Abteilung
Principal Investigator Name
Iordanis Deligiannis
Principal Investigator Email
i.deligiannis@bbtgruppe.de
Contact Person Name
Iordanis Deligiannis
Contact Person Email
i.deligiannis@bbtgruppe.de
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Markuskrankenhaus
Principal Investigator Name
Silvan Becker
Principal Investigator Email
silvan.becker@agaplesion.de
Contact Person Name
Silvan Becker
Contact Person Email
silvan.becker@agaplesion.de
Site Name
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU
Department Name
Hämatologie / Onkologie
Principal Investigator Name
Christian Spoer
Principal Investigator Email
Christian.spoer@donau-isar-klinikum.de
Contact Person Name
Christian Spoer
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinikum Spandau Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie
Principal Investigator Name
Jörg Rath
Principal Investigator Email
joerg-christian.rath@vivantes.de
Contact Person Name
Jörg Rath
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Kliniken der Stadt Koeln gGmbH
Principal Investigator Name
Bernhard Sibbing
Principal Investigator Email
SibbingB@kliniken-koeln.de
Contact Person Name
Bernhard Sibbing
Contact Person Email
SibbingB@kliniken-koeln.de
Site Name
Marien Gesellschaft Siegen gGmbH
Department Name
Marien Kliniken - St. Marien-Krankenhaus Siegen
Principal Investigator Name
Elisabeth Mack
Principal Investigator Email
e.mack@mariengesellschaft.de
Contact Person Name
Elisabeth Mack
Contact Person Email
e.mack@mariengesellschaft.de
Site Name
Johanniter GmbH
Department Name
Johanniter Krankenhaus Bonn
Principal Investigator Name
Yon-Dschun Ko
Principal Investigator Email
Yon-Dschun.Ko@bn.johanniter-kliniken.de
Contact Person Name
Yon-Dschun Ko
Site Name
Onkozentrum Dresden Freiberg Meissen
Department Name
Hämatologie und internistische Onkologie Med. Tumortherapie, Palliativmedizin
Principal Investigator Name
Steffen Dörfel
Principal Investigator Email
doerfel@onkozentrum.de
Contact Person Name
Steffen Dörfel
Contact Person Email
doerfel@onkozentrum.de
Site Name
OnkoNet Marburg GmbH
Department Name
OnkoNet Marburg GmbH
Principal Investigator Name
Christina Balser
Principal Investigator Email
drbalser@gmx.de
Contact Person Name
Christina Balser
Contact Person Email
drbalser@gmx.de
Site Name
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Department Name
Klinik für Onkologie und Hämatologie
Principal Investigator Name
Anke Schlenska-Lange
Contact Person Name
Anke Schlenska-Lange
Site Name
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Department Name
Klinik für Innere Medizin
Principal Investigator Name
Stefan Angermeier
Principal Investigator Email
stefan.angermeier@rkh-kliniken.de
Contact Person Name
Stefan Angermeier
Site Name
Klinikum Lippe GmbH
Department Name
Klinikum Lippe GmbH
Principal Investigator Name
Christian Constantin
Principal Investigator Email
Christian.Constantin@klinikum-lippe.de
Contact Person Name
Christian Constantin
Site Name
Klinikum Landshut AdoeR der Stadt Landshut
Department Name
Medizinische Klinik III
Principal Investigator Name
Christian Bogner
Principal Investigator Email
christian.bogner@klinikum-landshut.de
Contact Person Name
Christian Bogner
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Tumorzentrum Eva Mayr-Stihl
Principal Investigator Name
Wolfram Bohle
Principal Investigator Email
w.bohle@klinikum-stuttgart.de
Contact Person Name
Wolfram Bohle
Contact Person Email
w.bohle@klinikum-stuttgart.de
Site Name
Muehlenkreiskliniken AöR
Department Name
Johannes Wesling Klinikum Minden
Principal Investigator Name
Hans-Joachim Tischler
Contact Person Name
Hans-Joachim Tischler
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Udo Lindig
Principal Investigator Email
Udo.lindig@med.uni-jena.de
Contact Person Name
Udo Lindig
Contact Person Email
Udo.lindig@med.uni-jena.de
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Abteilung für Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Anke Reinacher-Schick
Principal Investigator Email
anke.reinacher@rub.de
Contact Person Name
Anke Reinacher-Schick
Contact Person Email
anke.reinacher@rub.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinikum Chemnitz
Principal Investigator Name
Jack Chater
Principal Investigator Email
j.chater@skc.de
Contact Person Name
Jack Chater
Contact Person Email
j.chater@skc.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Abtl. Chirurgie
Principal Investigator Name
Hans Schlitt
Principal Investigator Email
hans.schlitt@ukr.de
Contact Person Name
Hans Schlitt
Contact Person Email
hans.schlitt@ukr.de
Site Name
Schwerpunktpraxis für Hämatologie und Onkologie Penzberg/Weilheim
Department Name
Schwerpunktpraxis für Hämatologie und Onkologie Penzberg/Weilheim
Principal Investigator Name
Michael Sandherr
Principal Investigator Email
heinemannpraxout@t-online.de
Contact Person Name
Michael Sandherr
Contact Person Email
heinemannpraxout@t-online.de
Site Name
Klinikum Ernst von Bergmann gGmbH
Department Name
Klinik für Hämatologie Onkologie und Palliativmedizin
Principal Investigator Name
Matthias Paland
Principal Investigator Email
matthias.paland@klinikumevb.de
Contact Person Name
Matthias Paland
Contact Person Email
matthias.paland@klinikumevb.de
Site Name
Klinikum Magdeburg gGmbH
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Christoph Kahl
Principal Investigator Email
christoph.kahl@klinikum-magdeburg.de
Contact Person Name
Christoph Kahl
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik und Poliklinik für Innere Medizin III
Principal Investigator Name
Sylvie Lorenzen
Principal Investigator Email
sylvie.lorenzen@mri.tum.de
Contact Person Name
Sylvie Lorenzen
Contact Person Email
sylvie.lorenzen@mri.tum.de
Site Name
St. Anna Hospital
Department Name
St. Elisabeth Gruppe GmbH
Principal Investigator Name
Viktor Rempel
Principal Investigator Email
viktor.rempel@elisabethgruppe.de
Contact Person Name
Viktor Rempel
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Gastroenterologie
Principal Investigator Name
Thomas Wirth
Principal Investigator Email
wirth.thomas@mh-hannover.de
Contact Person Name
Thomas Wirth
Contact Person Email
wirth.thomas@mh-hannover.de
Site Name
Klinikum Darmstadt GmbH
Department Name
Medizinische Klinik II-Gastroenterologie, Hepatopankreatologie, Diabetologie und Pneumonie
Principal Investigator Name
Carl Schimanski
Principal Investigator Email
carl.schimanski@mail.klinikum-darmstadt.de
Contact Person Name
Carl Schimanski
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Med. Klinik
Principal Investigator Name
Marianne Sinn
Principal Investigator Email
ma.sinn@uke.de
Contact Person Name
Marianne Sinn
Contact Person Email
ma.sinn@uke.de
Site Name
Praxis für Hämatologie und Onkologie Gießen
Department Name
Praxis für Hämatologie und Onkologie Gießen
Principal Investigator Name
Georg Schliesser
Principal Investigator Email
schliesser@onkologie-praxis-giessen.de
Contact Person Name
Georg Schliesser
Site Name
Klinikum Rheine Mathias-Spital
Department Name
Klinik für Innere Medizin VI
Principal Investigator Name
Sebastian Bröckling
Principal Investigator Email
s.broeckling@mathias-stiftung.de
Contact Person Name
Sebastian Bröckling
Site Name
Kreiskliniken Reutlingen gGmbH
Department Name
Medizinische Klinik I
Principal Investigator Name
Stefan Kubicka
Principal Investigator Email
kubicka_s@klin-rt.de
Contact Person Name
Stefan Kubicka
Contact Person Email
kubicka_s@klin-rt.de

Sponsor

Primary sponsor

Full Name
Charite Universitaetsmedizin Berlin KöR
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Third parties

  • {"country":"Germany","full_name":"Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH","duties_or_roles":"1,11,12,13,2,5,6,7,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
CALCIUM FOLINATE PENTAHYDRATE
Active Substance
CALCIUM FOLINATE PENTAHYDRATE
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
2
Maximum Dose
400 mg/m2
Investigational Product Name
DISODIUM FOLINATE
Active Substance
DISODIUM FOLINATE
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
2
Maximum Dose
400 mg/m2
Investigational Product Name
OXALIPLATIN
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
2
Maximum Dose
130 mg/m2
Investigational Product Name
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Active Substance
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
2
Maximum Dose
180 mg/m2
Investigational Product Name
FLUOROURACIL
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
2
Maximum Dose
2400 mg/m2
Investigational Product Name
CAPECITABINE
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Maximum Dose
1000 mg/m2
Combination Treatment
Yes

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