Clinical trial • Phase III • Oncology

OXALIPLATIN for High-risk stage III colon cancer

Phase III trial of OXALIPLATIN for High-risk stage III colon cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
High-risk stage III colon cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-08-2024
First CTIS Authorization Date
10-10-2024

Trial design

Randomised, comparator arm: mfolfox (oxaliplatin + folinic acid + fluorouracil). experimental arm: mfolfirinox (irinotecan + oxaliplatin + folinic acid + fluorouracil). doses (maximum/daily amounts reported in part i product entries): oxaliplatin up to 85 mg/m2; irinotecan up to 180 mg/m2; folinic acid up to 400 mg/m2; fluorouracil up to 2400 mg/m2. schedule not specified in ctis record.-controlled Phase III trial across 56 sites in France, Italy.

Randomised
Yes
Comparator
Comparator arm: mFOLFOX (oxaliplatin + folinic acid + fluorouracil). Experimental arm: mFOLFIRINOX (irinotecan + oxaliplatin + folinic acid + fluorouracil). Doses (maximum/daily amounts reported in Part I product entries): Oxaliplatin up to 85 mg/m2; Irinotecan up to 180 mg/m2; Folinic acid up to 400 mg/m2; Fluorouracil up to 2400 mg/m2. Schedule not specified in CTIS record.
Target Sample Size
66
Trial Duration For Participant
1095

Eligibility

Recruits 66 Vulnerable population flag is selected in CTIS. Inclusion requires: 'Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures'. Patients with 'Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent' are excluded. Consent is obtained from the patient; no minors are included (minimum age ≥18)..

Pregnancy Exclusion
Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period
Vulnerable Population
Vulnerable population flag is selected in CTIS. Inclusion requires: 'Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures'. Patients with 'Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent' are excluded. Consent is obtained from the patient; no minors are included (minimum age ≥18).

Inclusion criteria

  • {"criterion_text":"- Patient ≥18 years and < 75 years\n- Patient ≥18 years and <71 years must have an ECOG ≤1 – Patients ≥71 years and < 75 years must have an ECOG = 0\n- Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor.\n- Curative R0 surgical resection.\n- Patients who have undergone surgery for colon cancer, defined as a tumor location >12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum), without gross or microscopic evidence of residual disease after surgery with curative intent\n- Start of study drug treatment has to be performed less than 56 days after surgery.\n- No prior chemotherapy.\n- No prior abdominal or pelvic irradiation.\n- Patient with adequate organ function: - Absolute neutrophil count (ANC) ≥ 2 x 109/L - Haemoglobin ≥9 g/dL - Platelets (PTL) ≥100 x 109/L - AST/ALT ≤2.5 x ULN - Alkaline phosphatase ≤2.5 x ULN - Total Bilirubin ≤1.5 x ULN (Upper Limit of Normal) - Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula) - Kalemia, magnesemia, calcemia ≥ 1 LLN (Lower Limit of Normal) - Carcinoembryogenic antigen (CEA) ≤10ng/mL after surgery (during screening period)\n- Adequate contraception if applicable.\n- Patient able and willing to comply with study procedures as per protocol\n- Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures\n- Public or private health insurance coverage\n- Life expectancy of > or = at 5 years\n- Uracilemia < 16 ng/ml (only for french centers)"}

Exclusion criteria

  • {"criterion_text":"- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study\n- Any significant disease which, in the investigator’s opinion, would exclude the patient from the study.\n- Patient with a DPD deficiency or UGT1A1 homozygous 7/7; the test should be done for all patients before 5-FU administration, according to ANSM communication regarding recommendation about high risk of no testing DPD in patient before 5-FU administration;\n- Patients already included in another therapeutic trial involving an experimental drug\n- Metastatic disease\n- Presence of inflammatory bowel disease and/or ileus\n- Known hypersensitivity reaction to any of the components of study treatments.\n- Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period\n- Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for women: QTc ≥470 msec)\n- Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix\n- Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent\n- History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v4.03."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary end-point is the Disease Free Survival (DFS) at 3 years, defined as the time from the date of randomization up to the date of: - first local, regional or distant relapse; - second colorectal cancer; - death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored.","definition_or_measurement_approach":"DFS at 3 years defined as time from randomization to first local, regional or distant relapse, second colorectal cancer, or death from any cause (including treatment-related death). Other primary cancers (except second primary colorectal) are ignored."}

Secondary endpoints

  • {"endpoint_text":"- Evaluation of Efficacy: The evaluation of efficacy is defined as the Disease Free Survival at 2 years, defined as the time from the date of randomization up to the date of: - first local, regional or distant relapse - second colorectal cancer - death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored.","definition_or_measurement_approach":"DFS at 2 years defined as time from randomization to first local, regional or distant relapse, second colorectal cancer, or death from any cause (including treatment-related death). Other primary cancers (except second primary colorectal) are ignored."}
  • {"endpoint_text":"- Overall Survival (OS): Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause.","definition_or_measurement_approach":"OS defined as time from randomization to documented death from any cause."}
  • {"endpoint_text":"- Evaluation of Toxicity: Safety of the study treatment will be assessed on occurrence of Adverse Events (AEs), intake of concomitant treatments, per-treatment arising changes in physical examination, vital signs (blood pressure, pulse rate and body temperature), ECG, and clinical laboratory tests (biochemistry, haematology). Safety parameters will be graded based on NCI CTCAE v4.03 classification.","definition_or_measurement_approach":"Safety assessed by occurrence of AEs, concomitant treatments, changes in physical exam, vital signs, ECG, lab tests; graded by NCI CTCAE v4.03."}

Recruitment

Planned Sample Size
66
Recruitment Window Months
109
Consent Approach
Written voluntary informed consent signed and dated by the patient at the screening visit prior to any protocol-specific procedures. ICF templates are present in CTIS (L1_SIS and ICF documents for national parts). No assent or parental consent processes are indicated (minimum age ≥18).

Geography

Total Number Of Sites
56
Total Number Of Participants
66

France

Earliest CTIS Part Ii Submission Date
22-08-2024
Latest Decision Or Authorization Date
10-10-2024
Processing Time Days
49
Number Of Sites
42
Number Of Participants
50

Sites

Site Name
CLINIQUE MUTUALISTE DE L'ESTUAIRE
Department Name
Oncologie Médicale
Principal Investigator Name
Catherine LIGEZA
Principal Investigator Email
catherine.ligeza@mla.fr
Contact Person Name
Catherine LIGEZA
Contact Person Email
catherine.ligeza@mla.fr
Site Name
Reseau De Sante Mutualiste
Department Name
Gastroentérologie et cancérologie digestive
Principal Investigator Name
Marie-Anne GUILLAUMOT
Principal Investigator Email
ma.guillaumot@gelmad.fr
Contact Person Name
Marie-Anne GUILLAUMOT
Contact Person Email
ma.guillaumot@gelmad.fr
Site Name
GHBS Lorient
Department Name
Oncologie
Principal Investigator Name
Isabelle CUMIN
Principal Investigator Email
i.cumin@ghbs.bzh
Contact Person Name
Isabelle CUMIN
Contact Person Email
i.cumin@ghbs.bzh
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Hepato Gastro-Entérologie
Principal Investigator Name
Jean-Baptiste BACHET
Principal Investigator Email
jean-baptiste.bachet@aphp.fr
Contact Person Name
Jean-Baptiste BACHET
Contact Person Email
jean-baptiste.bachet@aphp.fr
Site Name
CHU De Toulouse -Hopital Rangueil
Department Name
Oncologie Médicale
Principal Investigator Name
Rosine GUIMBAUD
Principal Investigator Email
guimbaud.r@chu-toulouse.fr
Contact Person Name
Rosine GUIMBAUD
Contact Person Email
guimbaud.r@chu-toulouse.fr
Site Name
Centre Hospitalier D Auxerre
Department Name
Oncologie Médicale
Principal Investigator Name
Anne-Laure VILLING
Principal Investigator Email
alvilling@ch-auxerre.fr
Contact Person Name
Anne-Laure VILLING
Contact Person Email
alvilling@ch-auxerre.fr
Site Name
Institut Godinot
Department Name
Oncologie medicale
Principal Investigator Name
Damien BOTSEN
Principal Investigator Email
damien.botsen@reims.unicancer.fr
Contact Person Name
Damien BOTSEN
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Oncologie Médicale
Principal Investigator Name
Olivier DUBREUIL
Principal Investigator Email
odubreuil@hopital-dcss.org
Contact Person Name
Marie-Anne GUILLAUMOT
Contact Person Email
ma.guillaumot@gelmad.fr
Site Name
CHRU de Tours- Hôpital Trousseau
Department Name
Hépato-gastroenterologie
Principal Investigator Name
Thierry LECOMTE
Principal Investigator Email
thierry.lecomte@med.univ-tours.fr
Contact Person Name
Thierry LECOMTE
Site Name
Centre Hospitalier Valence
Department Name
Hepato Gastro-Entérologie
Principal Investigator Name
Nicolas ETCHEPARE
Principal Investigator Email
netchepare@ch-valence.fr
Contact Person Name
Nicolas ETCHEPARE
Contact Person Email
netchepare@ch-valence.fr
Site Name
Hospital Foch
Department Name
Oncologie Médicale
Principal Investigator Name
Asmahane BENMAZIANE-TEILLET
Principal Investigator Email
a.benmaziane@hopital-foch.com
Contact Person Name
Jean-Baptiste BACHET
Contact Person Email
jean-baptiste.bachet@aphp.fr
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie Médicale
Principal Investigator Name
Jérôme BARRIERE
Principal Investigator Email
docteurbarriere@outlook.fr
Contact Person Name
Jérôme BARRIERE
Contact Person Email
docteurbarriere@outlook.fr
Site Name
Hopital Europeen Marseille
Department Name
Oncologie
Principal Investigator Name
Yves RINALDI
Principal Investigator Email
y.rinaldi@hopital-europeen.fr
Contact Person Name
Yves RINALDI
Contact Person Email
y.rinaldi@hopital-europeen.fr
Site Name
Centre Hospitalier Victor Dupouy
Department Name
Oncologie
Principal Investigator Name
Julie BOISSET
Principal Investigator Email
julie.boisset@ch-argenteuil.fr
Contact Person Name
Julie BOISSET
Contact Person Email
julie.boisset@ch-argenteuil.fr
Site Name
Centre Hospitalier Saint Joseph Saint Luc
Department Name
Service de Gastroenterologie
Principal Investigator Name
Denis PÉRÉ-VERGÉ
Principal Investigator Email
dpereverge@ch-stjoseph-stluc-lyon.fr
Contact Person Name
Denis PÉRÉ-VERGÉ
Site Name
Institut De Cancerologie De L Ouest
Department Name
Département d'Oncologie
Principal Investigator Name
Sandrine HIRET
Principal Investigator Email
sandrine.hiret@ico.unicancer.fr
Contact Person Name
Sandrine HIRET
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Hépato Gastroentérologie
Principal Investigator Name
Guillaume ROQUIN
Principal Investigator Email
guillaume.roquin@chu-angers.fr
Contact Person Name
Guillaume ROQUIN
Contact Person Email
guillaume.roquin@chu-angers.fr
Site Name
Hôpital La Timone - APHM
Department Name
Service d'Oncologie Digestive
Principal Investigator Name
Laetitia DAHAN
Principal Investigator Email
laetitia.dahan@ap-hm.fr
Contact Person Name
Laetitia DAHAN
Contact Person Email
laetitia.dahan@ap-hm.fr
Site Name
Institut Gustave Roussy
Department Name
Département de Médecine / Comité 040
Principal Investigator Name
Valérie BOIGE
Principal Investigator Email
valerie.boige@gustaveroussy.fr
Contact Person Name
Valérie BOIGE
Contact Person Email
valerie.boige@gustaveroussy.fr
Site Name
Clinique De L'infirmerie Protestante De Lyon
Department Name
Service d'Hepato-gastro-enterologie
Principal Investigator Name
Johannes HARTWIG
Contact Person Name
Johannes HARTWIG
Site Name
Clinique De La Sauvegarde
Department Name
Oncologie
Principal Investigator Name
Philippe ARDISSON
Principal Investigator Email
ph.ardisson@wanadoo.fr
Contact Person Name
Philippe ARDISSON
Contact Person Email
ph.ardisson@wanadoo.fr
Site Name
Centre Hospitalier Prive Saint-Gregoire
Department Name
Service d'Oncologie
Principal Investigator Name
Clément PERRET
Principal Investigator Email
clperret@vivalto-sante.com
Contact Person Name
Clément PERRET
Contact Person Email
clperret@vivalto-sante.com
Site Name
Centre Hospitalier De Niort
Department Name
Pôle oncologie et Soins de support
Principal Investigator Name
Albert ALEBA
Principal Investigator Email
albert.aleba@ch-niort.fr
Contact Person Name
Albert ALEBA
Contact Person Email
albert.aleba@ch-niort.fr
Site Name
Hopital Saint Louis
Department Name
Oncologie
Principal Investigator Name
Thomas APARICIO
Principal Investigator Email
thomas.aparicio@aphp.fr
Contact Person Name
Thomas APARICIO
Contact Person Email
thomas.aparicio@aphp.fr
Site Name
Clinique Tivoli Ducos
Department Name
Service d'Oncologie-Radiothérapie
Principal Investigator Name
Pauline REGNAULT
Principal Investigator Email
p.regnault@tivoli-oncologie.fr
Contact Person Name
Pauline REGNAULT
Contact Person Email
p.regnault@tivoli-oncologie.fr
Site Name
Centre Hospitalier De Pau
Department Name
Service d'hépato-gastroentérologie
Principal Investigator Name
Juliette THAURY
Principal Investigator Email
juliette.thaury@ch-pau.fr
Contact Person Name
Juliette THAURY
Contact Person Email
juliette.thaury@ch-pau.fr
Site Name
Institut Sainte Catherine
Department Name
Service d'Oncologie-Radiothérapie
Principal Investigator Name
Laurent MINEUR
Principal Investigator Email
l.mineur@isc84.org
Contact Person Name
Laurent MINEUR
Contact Person Email
l.mineur@isc84.org
Site Name
Clinique Victor Hugo
Department Name
Oncologie-Radiothérapie
Principal Investigator Name
Olivier DUPUIS
Principal Investigator Email
o.dupuis@cjb72.org
Contact Person Name
Olivier DUPUIS
Contact Person Email
o.dupuis@cjb72.org
Site Name
Institut De Cancerologie De L Ouest (Angers address)
Department Name
Département d'Oncologie
Principal Investigator Name
Sandrine HIRET
Principal Investigator Email
sandrine.hiret@ico.unicancer.fr
Contact Person Name
Sandrine HIRET
Site Name
Centre Hospitalier De Cholet
Department Name
Service d'Oncologie médicale
Principal Investigator Name
You-Heng LAM
Principal Investigator Email
you-heng.lam@ch-cholet.fr
Contact Person Name
You-Heng LAM
Contact Person Email
you-heng.lam@ch-cholet.fr
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Oncologie
Principal Investigator Name
Emmanuel GUARDIOLA
Principal Investigator Email
eguardiola@oncoclem.org
Contact Person Name
Emmanuel GUARDIOLA
Contact Person Email
eguardiola@oncoclem.org
Site Name
Hopital Prive Jean Mermoz
Department Name
Institut de Cancérologie
Principal Investigator Name
Pascal ARTRU
Principal Investigator Email
dr.artru@wanadoo.fr
Contact Person Name
Pascal ARTRU
Contact Person Email
dr.artru@wanadoo.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d'Oncologie digestive
Principal Investigator Name
Eric TERREBONNE
Principal Investigator Email
eric.terrebonne@chu-bordeaux.fr
Contact Person Name
Eric TERREBONNE
Site Name
Centr Georges Francois Leclerc
Department Name
Service d'Oncologie Medicale 3ème etage
Principal Investigator Name
Leila BENGRINE LEFEVRE
Principal Investigator Email
lbengrine@cgfl.fr
Contact Person Name
Leila BENGRINE LEFEVRE
Contact Person Email
lbengrine@cgfl.fr
Site Name
Hôpital Privé de Villeneuve d'Ascq Institut de Cancérologie
Department Name
Institut de Cancérologie
Principal Investigator Name
Olivier ROMANO
Principal Investigator Email
romanoolivier@yahoo.fr
Contact Person Name
Olivier ROMANO
Contact Person Email
romanoolivier@yahoo.fr
Site Name
Clinique Saint Anne
Department Name
Oncologie
Principal Investigator Name
Gratiane COGNIET
Principal Investigator Email
gchatelin@hotmail.com
Contact Person Name
Gratiane COGNIET
Contact Person Email
gchatelin@hotmail.com
Site Name
Centre Hospitalier De Boulogne Sur Mer
Department Name
Service d'Oncologie digestive
Principal Investigator Name
Vincent BOURGEOIS
Principal Investigator Email
vincebourgeois@hotmail.com
Contact Person Name
Vincent BOURGEOIS
Contact Person Email
vincebourgeois@hotmail.com
Site Name
Les Hopitaux De Chartres
Department Name
Oncologie Médicale
Principal Investigator Name
Chloé GENET
Principal Investigator Email
cgenet@ch-chartres.fr
Contact Person Name
Chloé GENET
Contact Person Email
cgenet@ch-chartres.fr
Site Name
Centre Hospitalier D Avignon
Department Name
Hépato Gastroentérologie
Principal Investigator Name
Thibault BROTELLE
Principal Investigator Email
brotelle.thibault@ch-avignon.fr
Contact Person Name
Thibault BROTELLE
Site Name
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
Department Name
Département d'Oncologie médicale
Principal Investigator Name
Cécile LEYRONNAS
Principal Investigator Email
cecile.leyronnas@avec.fr
Contact Person Name
Cécile LEYRONNAS
Contact Person Email
cecile.leyronnas@avec.fr
Site Name
Capio La Croix Du Sud
Department Name
Oncologie
Principal Investigator Name
Anne-Pascale LAURENTY
Principal Investigator Email
anne-pascale.laurenty@ramsaysante.fr
Contact Person Name
Anne-Pascale LAURENTY
Site Name
Centre Hospitalier de Saintes
Department Name
Service d'Oncologie médicale
Principal Investigator Name
Florence BORDE
Principal Investigator Email
f.borde@ch-saintonge.fr
Contact Person Name
Florence BORDE
Contact Person Email
f.borde@ch-saintonge.fr

Italy

Earliest CTIS Part Ii Submission Date
22-08-2024
Latest Decision Or Authorization Date
15-10-2024
Processing Time Days
54
Number Of Sites
14
Number Of Participants
16

Sites

Site Name
Fondazione PTV Policlinico Tor Vergata
Department Name
U.O.S.D. Oncologia Medica
Principal Investigator Name
Vincenzo FORMICA
Principal Investigator Email
v.formica1@gmail.com
Contact Person Name
Vincenzo FORMICA
Contact Person Email
v.formica1@gmail.com
Site Name
Fondazione Poliambulanza
Department Name
U.O. Oncologia Medica
Principal Investigator Name
Alaberto ZANIBONI
Principal Investigator Email
oncotrials@poliambulanza.it
Contact Person Name
Alaberto ZANIBONI
Contact Person Email
oncotrials@poliambulanza.it
Site Name
Ente Ospedaliero Ospedali Galliera Di Genova
Department Name
SC Oncologia Medica
Principal Investigator Name
Matteo CLAVAREZZA
Principal Investigator Email
matteo.clavarezza@galliera.it
Contact Person Name
Matteo CLAVAREZZA
Contact Person Email
matteo.clavarezza@galliera.it
Site Name
A.O. S. Croce e Carle di Cuneo
Department Name
Oncology Department
Principal Investigator Name
Cristina GRANETTO
Principal Investigator Email
granetto.c@ospedale.cuneo.it
Contact Person Name
Cristina GRANETTO
Contact Person Email
granetto.c@ospedale.cuneo.it
Site Name
Azienda Ospedaliera Universitaria Careggi
Department Name
Oncologia Medica
Principal Investigator Name
Lorenzo ANTONUZZO
Principal Investigator Email
oncmedmd@aou-careggi.toscana.it
Contact Person Name
Lorenzo ANTONUZZO
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncologia Medica
Principal Investigator Name
Giampaolo TORTORA
Principal Investigator Email
giampaolo.tortora@policlinicogemelli.it
Contact Person Name
Giampaolo TORTORA
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 2 Universitaria
Principal Investigator Name
Chiara CREMOLINI
Principal Investigator Email
chiaracremolini@gmail.com
Contact Person Name
Chiara CREMOLINI
Contact Person Email
chiaracremolini@gmail.com
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica
Principal Investigator Name
Filippo PIETRANTONIO
Principal Investigator Email
filippo.pietrantonio@unimi.it
Contact Person Name
Filippo PIETRANTONIO
Contact Person Email
filippo.pietrantonio@unimi.it
Site Name
Policlinico Universitario Campus Bio-Medico
Department Name
Oncologia Medica
Principal Investigator Name
Daniele SANTINI
Principal Investigator Email
d.santini@unicampus.it
Contact Person Name
Daniele SANTINI
Contact Person Email
d.santini@unicampus.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Oncologia
Principal Investigator Name
Alberto BALLESTRERO
Principal Investigator Email
aballestrero@unige.it
Contact Person Name
Alberto BALLESTRERO
Contact Person Email
aballestrero@unige.it
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
UOC Oncologia Medica
Principal Investigator Name
Giacomo ALLEGRINI
Principal Investigator Email
giacomo.allegrini@uslnordovest.toscana.it
Contact Person Name
Giacomo ALLEGRINI
Site Name
Istituto Oncologico Veneto
Department Name
SC Oncologia 1
Principal Investigator Name
Sara LONARDI
Principal Investigator Email
sara.lonardi@iov.veneto.it
Contact Person Name
Sara LONARDI
Contact Person Email
sara.lonardi@iov.veneto.it
Site Name
Azienda USL Toscana Centro
Department Name
UO Oncologia
Principal Investigator Name
Samantha DI DONATO
Principal Investigator Email
samantha.didonato@uslcentro.toscana.it
Contact Person Name
Samantha DI DONATO
Site Name
Ospedale San Bortolo di Vicenza
Department Name
UOC Oncologia Medica
Principal Investigator Name
Giuseppe APRILE
Principal Investigator Email
giuseppe.aprile@aulss8.veneto.it
Contact Person Name
Giuseppe APRILE

Sponsor

Primary sponsor

Full Name
Unicancer
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
OXALIPLATIN
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Dose Levels
85 mg/m2 (maxDailyDoseAmount)
Maximum Dose
85 mg/m2
Investigational Product Name
FOLINIC ACID
Active Substance
FOLINIC ACID
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Dose Levels
400 mg/m2 (maxDailyDoseAmount)
Maximum Dose
400 mg/m2
Investigational Product Name
IRINOTECAN
Active Substance
IRINOTECAN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Dose Levels
180 mg/m2 (maxDailyDoseAmount)
Maximum Dose
180 mg/m2
Investigational Product Name
FLUOROURACIL
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Dose Levels
2400 mg/m2 (maxDailyDoseAmount)
Maximum Dose
2400 mg/m2
Combination Treatment
Yes

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