Clinical trial • Phase III • Oncology|Gastroenterology
CAPECITABINE for Locally recurrent rectal cancer
Phase III trial of CAPECITABINE for Locally recurrent rectal cancer.
Overview
- Trial Therapeutic Area
- Oncology|Gastroenterology
- Trial Disease
- Locally recurrent rectal cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 18-03-2024
- First CTIS Authorization Date
- 12-04-2024
Trial design
Randomised, open-label, chemoradiotherapy alone as neoadjuvant treatment (chemoradiotherapy-only arm). no specific drug names, doses or schedules are specified in the ctis part i/part ii data.-controlled Phase III trial in Belgium, Portugal, Sweden and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Chemoradiotherapy alone as neoadjuvant treatment (chemoradiotherapy-only arm). No specific drug names, doses or schedules are specified in the CTIS Part I/Part II data.
- Target Sample Size
- 364
Eligibility
Recruits 364 No vulnerable populations selected; trial enrols adults (18 years or older) only. Written informed consent is required from participants. No assent or paediatric consent procedures are described in the CTIS record..
- Pregnancy Exclusion
- Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction, thrombocytopenia), as determined by the medical oncologist.
- Vulnerable Population
- No vulnerable populations selected; trial enrols adults (18 years or older) only. Written informed consent is required from participants. No assent or paediatric consent procedures are described in the CTIS record.
Inclusion criteria
- {"criterion_text":"- 18 years or older\n- Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal cancer or distal sigmoidal cancer, either by; histopathology ór; clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)\n- Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy. Expected gross incomplete resection with overt tumour remaining in the patient after resection, encasement of the ischiadic nerve and invasion of the cortex and/or neuroforamina from S2 and upwards are considered not resectable.\n- WHO performance score 0-1\n- Written informed consent"}
Exclusion criteria
- {"criterion_text":"- Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation. Patients with enlarged iliac lymph nodes, enlarged inguinal lymph nodes and aspecific lung noduli are not excluded from inclusion.\n- Homozygous DPD deficiency (if known in advance)\n- Any chemotherapy in the past 6 months.\n- Radiotherapy in the past 6 months for primary rectal cancer.\n- Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction, thrombocytopenia), as determined by the medical oncologist.\n- Any contraindication for the planned chemoradiotherapy (e.g. severe allergy to chemotherapy agent, no possibility for radiotherapy due to previous radiotherapy), as determined by the medical oncologist and/or radiation oncologist.\n- Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist.\n- Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The rate of clear resection margins after surgery","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Local re-recurrence free survival\n- Progression free survival\n- Distant metastasis free survival\n- Disease free survival\n- Overall survival\n- Pathologic response\n- Radiological response\n- Systemic therapy related toxicity (NCI-CTCAE v5.0 grade ≥3)\n- The number of patients completing neoadjuvant treatment\n- Surgical characteristics\n- Major postoperative complications (Clavien-Dindo ≥3) up to 90-days postoperatively\n- Quality of life\n- Cost-effectiveness","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 364
- Recruitment Window Months
- 144
- Consent Approach
- Written informed consent is required from participants (document referenced: L1_SIS and ICF). Participants are adults (≥18 years); no paediatric assent procedures are described. Languages of the consent forms are not specified in the CTIS record.
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 364
Belgium
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 557
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Surgery
- Principal Investigator Name
- Gabrielle van Ramshorst
- Principal Investigator Email
- gabrielle.vanramshorst@uzgent.be
- Contact Person Name
- Gabrielle van Ramshorst
- Contact Person Email
- gabrielle.vanramshorst@uzgent.be
Portugal
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 557
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
- Department Name
- Surgery
- Principal Investigator Name
- João Maciel
- Principal Investigator Email
- jmaciel@ipolisboa.min-saude.pt
- Contact Person Name
- João Maciel
- Contact Person Email
- jmaciel@ipolisboa.min-saude.pt
Sweden
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 557
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Surgery
- Principal Investigator Name
- Pamela Buchwald
- Principal Investigator Email
- pamela.buchwald@skane.se
- Contact Person Name
- Pamela Buchwald
- Contact Person Email
- pamela.buchwald@skane.se
- Site Name
- Karolinska University Hospital
- Department Name
- Surgery
- Principal Investigator Name
- Henrik Iversen
- Principal Investigator Email
- henrik.iversen@sll.se
- Contact Person Name
- Henrik Iversen
- Contact Person Email
- henrik.iversen@sll.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Surgery
- Principal Investigator Name
- Eva Angenete
- Principal Investigator Email
- eva.angenete@vgregion.se
- Contact Person Name
- Eva Angenete
- Contact Person Email
- eva.angenete@vgregion.se
Norway
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 557
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Oncology
- Principal Investigator Name
- Marianne Guren
- Principal Investigator Email
- marianne.gronlie.guren@ous-hf.no
- Contact Person Name
- Marianne Guren
- Contact Person Email
- marianne.gronlie.guren@ous-hf.no
Netherlands
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 680
- Number Of Sites
- 27
- Number Of Participants
- 280
Sites
- Site Name
- Jeroen Bosch Ziekenhuis
- Department Name
- Medical Oncology
- Principal Investigator Name
- ML Wumkes
- Principal Investigator Email
- m.wumkes@jbz.nl
- Contact Person Name
- ML Wumkes
- Contact Person Email
- m.wumkes@jbz.nl
- Site Name
- Radboud universitair medisch centrum / RADBOUDUMC
- Department Name
- Medical Oncology
- Principal Investigator Name
- Elske Gootjes
- Principal Investigator Email
- elkse.gootjes@radboudumc.nl
- Contact Person Name
- Elske Gootjes
- Contact Person Email
- elkse.gootjes@radboudumc.nl
- Site Name
- Isala Klinieken Stichting
- Department Name
- Surgery
- Principal Investigator Name
- H van Westreenen
- Principal Investigator Email
- h.l.van.westreenen@isala.nl
- Contact Person Name
- H van Westreenen
- Contact Person Email
- h.l.van.westreenen@isala.nl
- Site Name
- Elisabeth-Tweesteden Ziekenhuis
- Department Name
- Medical Oncology
- Principal Investigator Name
- Robbert J van Alphen
- Principal Investigator Email
- rvalphen@etz.nl
- Contact Person Name
- Robbert J van Alphen
- Contact Person Email
- rvalphen@etz.nl
- Site Name
- Dr. Bernard Verbeeten Instituut Stichting
- Department Name
- Radiation Oncology
- Principal Investigator Name
- Tom Rozema
- Principal Investigator Email
- vermaire.j@bvi.nl
- Contact Person Name
- Tom Rozema
- Contact Person Email
- vermaire.j@bvi.nl
- Site Name
- Zuidwest Radiotherapeutisch Instituut
- Department Name
- Radiation Oncology
- Principal Investigator Name
- M. Leseman
- Principal Investigator Email
- t.leseman@zrti.nl
- Contact Person Name
- M. Leseman
- Contact Person Email
- t.leseman@zrti.nl
- Site Name
- Radiotherapeutisch Instituut Friesland
- Department Name
- Radiation Oncology
- Principal Investigator Name
- E Bantema-Joppe
- Principal Investigator Email
- e.j.bantema-joppe@skf-rif.nl
- Contact Person Name
- E Bantema-Joppe
- Contact Person Email
- e.j.bantema-joppe@skf-rif.nl
- Site Name
- Noordwest Ziekenhuisgroep Stichting
- Department Name
- Surgery
- Principal Investigator Name
- W Schreurs
- Principal Investigator Email
- w.h.schreurs@nwz.nl
- Contact Person Name
- W Schreurs
- Contact Person Email
- w.h.schreurs@nwz.nl
- Site Name
- Medisch Centrum Leeuwarden B.V.
- Department Name
- Surgery
- Principal Investigator Name
- C Hoff
- Principal Investigator Email
- c.hoff@mcl.nl
- Contact Person Name
- C Hoff
- Contact Person Email
- c.hoff@mcl.nl
- Site Name
- Medical Center Haaglanden
- Department Name
- Surgery
- Principal Investigator Name
- Marjolein Leeuwenburgh
- Principal Investigator Email
- m.leeuwenburgh@haaglandenmc.nl
- Contact Person Name
- Marjolein Leeuwenburgh
- Contact Person Email
- m.leeuwenburgh@haaglandenmc.nl
- Site Name
- University Hospital Maastricht
- Department Name
- Surgery
- Principal Investigator Name
- Jarno Melenhorst
- Principal Investigator Email
- jarno.melenhorst@mumc.nl
- Contact Person Name
- Jarno Melenhorst
- Contact Person Email
- jarno.melenhorst@mumc.nl
- Site Name
- Medisch Spectrum Twente
- Department Name
- Surgery
- Principal Investigator Name
- M Huisman
- Principal Investigator Email
- monique.huisman@mst.nl
- Contact Person Name
- M Huisman
- Contact Person Email
- monique.huisman@mst.nl
- Site Name
- Gelre Hospitals
- Department Name
- Surgery
- Principal Investigator Name
- P van Duijvendijk
- Principal Investigator Email
- p.van.duijvendijk@gelre.nl
- Contact Person Name
- P van Duijvendijk
- Contact Person Email
- p.van.duijvendijk@gelre.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Surgery
- Principal Investigator Name
- C Verhoef
- Principal Investigator Email
- c.verhoef@erasmusmc.nl
- Contact Person Name
- C Verhoef
- Contact Person Email
- c.verhoef@erasmusmc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Surgery
- Principal Investigator Name
- Arend Aalbers
- Principal Investigator Email
- a.aalbers@nki.nl
- Contact Person Name
- Arend Aalbers
- Contact Person Email
- a.aalbers@nki.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Surgery
- Principal Investigator Name
- Fabian Holman
- Principal Investigator Email
- f.a.holman@lumc.nl
- Contact Person Name
- Fabian Holman
- Contact Person Email
- f.a.holman@lumc.nl
- Site Name
- Maastro Clinic
- Department Name
- Radiation Oncology
- Principal Investigator Name
- Maaike Berbee
- Principal Investigator Email
- maaike.berbee@maastro.nl
- Contact Person Name
- Maaike Berbee
- Contact Person Email
- maaike.berbee@maastro.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Surgery
- Principal Investigator Name
- Klaas Havenga
- Principal Investigator Email
- k.havenga@umcg.nl
- Contact Person Name
- Klaas Havenga
- Contact Person Email
- k.havenga@umcg.nl
- Site Name
- Radiotherapiegroep
- Department Name
- Radiation Oncology
- Principal Investigator Name
- Mariska Den Hartogh
- Principal Investigator Email
- m.denhartogh@radiotherapiegroep.nl
- Contact Person Name
- Mariska Den Hartogh
- Contact Person Email
- m.denhartogh@radiotherapiegroep.nl
- Site Name
- Admiraal De Ruyter Ziekenhuis B.V.
- Department Name
- Surgery
- Principal Investigator Name
- R. de Vos tot Nederven Cappel
- Principal Investigator Email
- r.devostotnederveencappel@ardz.nl
- Contact Person Name
- R. de Vos tot Nederven Cappel
- Contact Person Email
- r.devostotnederveencappel@ardz.nl
- Site Name
- Sint Antonius Ziekenhuis Stichting
- Department Name
- Surgery
- Principal Investigator Name
- N Wijffels
- Principal Investigator Email
- n.wijffels@antoniusziekenhuis.nl
- Contact Person Name
- N Wijffels
- Contact Person Email
- n.wijffels@antoniusziekenhuis.nl
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Surgery
- Principal Investigator Name
- MAJ de Roos
- Principal Investigator Email
- mderoos@rijnstate.nl
- Contact Person Name
- MAJ de Roos
- Contact Person Email
- mderoos@rijnstate.nl
- Site Name
- Catharina Ziekenhuis Stichting
- Department Name
- Surgery
- Principal Investigator Name
- Pim Burger
- Principal Investigator Email
- pim.burger@catharinaziekenhuis.nl
- Contact Person Name
- Pim Burger
- Contact Person Email
- pim.burger@catharinaziekenhuis.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Surgery
- Principal Investigator Name
- Milan Richir
- Principal Investigator Email
- m.c.richir@umcutrecht.nl
- Contact Person Name
- Milan Richir
- Contact Person Email
- m.c.richir@umcutrecht.nl
- Site Name
- Amphia Hospital
- Department Name
- Surgery
- Principal Investigator Name
- Robert Coebergh Van Den Braak
- Principal Investigator Email
- rcoebergh@amphia.nl
- Contact Person Name
- Robert Coebergh Van Den Braak
- Contact Person Email
- rcoebergh@amphia.nl
- Site Name
- Academic Medical Center At The University Of Amsterdam
- Department Name
- Surgery
- Principal Investigator Name
- Jurriaan Tuynman
- Principal Investigator Email
- j.tuynman@amsterdamumc.nl
- Contact Person Name
- Jurriaan Tuynman
- Contact Person Email
- j.tuynman@amsterdamumc.nl
- Site Name
- Bravis Ziekenhuis
- Department Name
- Surgery
- Principal Investigator Name
- Hans Fabry
- Principal Investigator Email
- h.fabry@bravis.nl
- Contact Person Name
- Hans Fabry
- Contact Person Email
- h.fabry@bravis.nl
Sponsor
Primary sponsor
- Full Name
- Catharina Ziekenhuis Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Third parties
- {"country":"Netherlands","full_name":"IKNL","duties_or_roles":"sponsorDuties codes: 1,6; contact trialbureau@iknl.nl","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Netherlands","full_name":"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","duties_or_roles":"sponsorDuties code: 4; contact j.kraan@erasmusmc.nl","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Netherlands","full_name":"Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting","duties_or_roles":"sponsorDuties code: 4; contact p.snaebjornsson@nki.nl","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Xeloda 150 mg film-coated tablets
- Active Substance
- CAPECITABINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation present)
- Maximum Dose
- 2000 mg/m2
- Investigational Product Name
- Irinotecan Hydrochloride medac 20 mg/ml, concentrate for solution for infusion.
- Active Substance
- IRINOTECAN HYDROCHLORIDE TRIHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (marketing authorisation present)
- Maximum Dose
- 180 mg/m2
- Investigational Product Name
- Fluorouracil Injection, 50 mg/ml, solution for injection
- Active Substance
- FLUOROURACIL
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- Authorised (marketing authorisation present)
- Maximum Dose
- 2400 mg/m2
- Investigational Product Name
- Teysuno 15 mg/4.35 mg/11.8 mg hard capsules
- Active Substance
- TEGAFUR, GIMERACIL, OTERACIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation present)
- Maximum Dose
- 50 mg/m2
- Investigational Product Name
- Calcium Folinate 10 mg/ml Injection
- Active Substance
- FOLINIC ACID
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (marketing authorisation present)
- Maximum Dose
- 400 mg/m2
- Investigational Product Name
- Oxaliplatin 5 mg/ml concentrate for solution for infusion
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (marketing authorisation present)
- Maximum Dose
- 130 mg/m2
- Combination Treatment
- Yes
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