Clinical trial • Phase III • Oncology|Gastroenterology
ONDANSETRON for Metastatic colorectal cancer|Colorectal cancer with liver metastases
Phase III trial of ONDANSETRON for Metastatic colorectal cancer|Colorectal cancer with liver metastases. Randomised. 254 participants.
Overview
- Trial Therapeutic Area
- Oncology|Gastroenterology
- Trial Disease
- Metastatic colorectal cancer|Colorectal cancer with liver metastases
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-02-2024
- First CTIS Authorization Date
- 23-05-2024
Trial design
Randomised Phase III trial in France.
- Randomised
- Yes
- Target Sample Size
- 254
- Trial Duration For Participant
- 1095
Eligibility
Recruits 254 No vulnerable population selected; participants must be 18 years old or older. Informed consent is obtained from adult participants; subject information and informed consent documents for adults are provided (L1_SIS-ICF adults and patient-facing documents). Assent not applicable..
- Pregnancy Exclusion
- Known pregnancy (pregnancy test for women of childbearing) or breastfeeding women
- Vulnerable Population
- No vulnerable population selected; participants must be 18 years old or older. Informed consent is obtained from adult participants; subject information and informed consent documents for adults are provided (L1_SIS-ICF adults and patient-facing documents). Assent not applicable.
Inclusion criteria
- {"criterion_text":"- Histologically proven resected metachronous CLM with curative intent that could not be treated with perioperative oxaliplatin-based chemotherapy for oncologic or tolerability reasons. For this study, metachronous CLM is defined as liver recurrence occurring more than 12 months after treatment of the primary colorectal cancer\n- Patients must be 18 years old or older\n- A WHO performance status of 0 or 1\n- Participants must be affiliated to a social security scheme\n- No more than 10 treated CLM at surgery\n- At least 2 cycles and no more than 8 cycles of preoperative FOLFIRI based chemotherapy ± targeted therapy\n- Preoperative FOLFIRI based chemotherapy ± targeted therapy administered no more than 12 weeks before surgery\n- R0/R1resection ± radiofrequency ablation with curative intent of all liver deposits with no macroscopic residual liver disease\n- Objective response to preoperative therapy defined as complete or partial radiological response and/or major or complete pathologic response\n- No extrahepatic or residual liver disease on baseline work-up including thoraco-abdominal CT scan within 6 weeks after surgery. 1 non-specific lung nodule of less than 10 mm in maximum diameter is not considered as extra-hepatic metastases\n- Primary tumor (or liver metastasis) of CRC must be characterized for RAS and BRAF status\n- No contraindication to FOLFIRI based chemotherapy"}
Exclusion criteria
- {"criterion_text":"- Palliative/R2 resection of CLM\n- 10 lesions or more treated at the time of surgery\n- Patients undergoing only radiofrequency ablation of all liver deposit (this situation precludes the assessment of pathologic response to preoperative chemotherapy)\n- Extra-hepatic or residual metastasis of CRC\n- Absence of objective response to therapy (radiological or pathological response )\n- Inflammatory bowel disease\n- Known UGT1A1*28 allele homozygosity\n- Contraindications to investigational medicinal products (irinotecan, 5-FU, folinic acid) and to auxiliary medicinal products (ondansetron, methylprednisolone)\n- Known pregnancy (pregnancy test for women of childbearing) or breastfeeding women"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Disease-free survival rate at 3 years","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Overall survival at 3 years","definition_or_measurement_approach":""}
- {"endpoint_text":"- Liver-free survival at 3 years","definition_or_measurement_approach":""}
- {"endpoint_text":"- Extra -hepatic recurrence rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- Safety including chemotherapy associated toxicity assessed by International Common Terminology Criteria for Adverse Events (CTCAE) grading system","definition_or_measurement_approach":"Assessed by International Common Terminology Criteria for Adverse Events (CTCAE) grading system"}
- {"endpoint_text":"- Compliance defined as the ability to administrate a total of 12 cycles of FOLFIRI-based chemotherapy including preoperative treatment","definition_or_measurement_approach":"Defined as the ability to administer a total of 12 cycles of FOLFIRI-based chemotherapy including preoperative treatment"}
- {"endpoint_text":"- Rate of treatment of recurrence with curative intent","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 254
- Recruitment Window Months
- 72
- Consent Approach
- Informed consent is obtained from adult participants (participants must be 18 years or older). Subject information and consent documents for adults are provided (documents listed: L1_SIS-ICF adults; L2 patient-facing documents). No information on additional languages or assent procedures is provided.
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 254
France
- Earliest CTIS Part Ii Submission Date
- 03-04-2024
- Latest Decision Or Authorization Date
- 11-07-2025
- Processing Time Days
- 464
- Number Of Sites
- 28
- Number Of Participants
- 254
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- chirugie Digestive et oncologique
- Principal Investigator Name
- Stéphane BENOIST
- Principal Investigator Email
- stephane.benoist@aphp.fr
- Contact Person Name
- Stéphane BENOIST
- Contact Person Email
- stephane.benoist@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- oncologie digestive
- 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
- Institut Bergonie
- Department Name
- oncologie digestive
- Principal Investigator Name
- Simon PERNOT
- Principal Investigator Email
- s.pernot@bordeaux.unicancer.fr
- Contact Person Name
- Simon PERNOT
- Contact Person Email
- s.pernot@bordeaux.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Chirurgie Digestive
- Principal Investigator Name
- Hadrien TRANCHART
- Principal Investigator Email
- hadrien.tranchart@aphp.fr
- Contact Person Name
- Hadrien TRANCHART
- Contact Person Email
- hadrien.tranchart@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Chirurgie Digestive et transplantation
- Principal Investigator Name
- Stéphanie TRUANT
- Principal Investigator Email
- stephanie.truant@chu-lille.fr
- Contact Person Name
- Stéphanie TRUANT
- Contact Person Email
- stephanie.truant@chu-lille.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- chirugie Digestive et oncologique
- Principal Investigator Name
- Diane Goere
- Principal Investigator Email
- diane.goere@aphp.fr
- Contact Person Name
- Diane Goere
- Contact Person Email
- diane.goere@aphp.fr
- Site Name
- Hopital De La Croix Rousse
- Department Name
- chirugie Digestive et Générale
- Principal Investigator Name
- Jean-Yves MABRUT
- Principal Investigator Email
- jean-yves.mabrut@chu-lyon.fr
- Contact Person Name
- Jean-Yves MABRUT
- Contact Person Email
- jean-yves.mabrut@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- chirurgie viscérale et digestive
- Principal Investigator Name
- David BIRNAUM
- Principal Investigator Email
- david.birnaum@ap-hm.fr
- Contact Person Name
- David BIRNAUM
- Contact Person Email
- david.birnaum@ap-hm.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- chirugie Digestive et hépato-biliaire
- Principal Investigator Name
- Alexis LAURENT
- Principal Investigator Email
- laurent.alexis@aphp.fr
- Contact Person Name
- Alexis LAURENT
- Contact Person Email
- laurent.alexis@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- Gastroentérologie et oncologie Digestive
- Principal Investigator Name
- Laetitia DAHAN-ALCARAZ
- Principal Investigator Email
- laetitia.dahan@ap-hm.fr
- Contact Person Name
- Laetitia DAHAN-ALCARAZ
- Contact Person Email
- laetitia.dahan@ap-hm.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- chirugie Digestive et oncologique
- Principal Investigator Name
- Patrick PESSAUX
- Principal Investigator Email
- patrick.pessaux@chru-strasbourg.fr
- Contact Person Name
- Patrick PESSAUX
- Contact Person Email
- patrick.pessaux@chru-strasbourg.fr
- Site Name
- Besancon University Hospital Center
- Department Name
- chirugie Digestive et oncologique
- Principal Investigator Name
- Celia TURCO
- Principal Investigator Email
- cturco@chu-besancon.fr
- Contact Person Name
- Celia TURCO
- Contact Person Email
- cturco@chu-besancon.fr
- Site Name
- Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
- Department Name
- chirugie Digestive
- Principal Investigator Name
- Jerome LORIAU
- Principal Investigator Email
- jloriau@gmail.com
- Contact Person Name
- Jerome LORIAU
- Contact Person Email
- jloriau@gmail.com
- Site Name
- Hopital Prive Jean Mermoz
- Department Name
- Gastroentérologie et oncologie Digestive
- Principal Investigator Name
- Artru PASCAL
- Principal Investigator Email
- dr.artru@wanadoo.fr
- Contact Person Name
- Artru PASCAL
- Contact Person Email
- dr.artru@wanadoo.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Hépato gastroentérologie et oncologie digesetive
- Principal Investigator Name
- Phelip JEAN MARC
- Principal Investigator Email
- j.marc.phelip@chu-st-etienne.fr
- Contact Person Name
- Phelip JEAN MARC
- Contact Person Email
- j.marc.phelip@chu-st-etienne.fr
- Site Name
- CHRU De Nancy
- Department Name
- chirugie Digestive et oncologique
- Principal Investigator Name
- Ahmet AYAV
- Principal Investigator Email
- a.ayav@chru-nancy.fr
- Contact Person Name
- Ahmet AYAV
- Contact Person Email
- a.ayav@chru-nancy.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Gastroentérologie-cancérologie digestive
- Principal Investigator Name
- Olivier BOUCHE
- Principal Investigator Email
- obouche@chu-reims.fr
- Contact Person Name
- Olivier BOUCHE
- Contact Person Email
- obouche@chu-reims.fr
- Site Name
- Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
- Department Name
- oncologie digestive
- Principal Investigator Name
- Hélène FLESCH
- Principal Investigator Email
- Helene.flesch@avec.fr
- Contact Person Name
- Hélène FLESCH
- Contact Person Email
- Helene.flesch@avec.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Gastroentérologie et oncologie Digestive
- 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
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Maladies de l'appareil digestif
- Principal Investigator Name
- ASTRID LIEVRE
- Principal Investigator Email
- astrid.lievre@chu-rennes.fr
- Contact Person Name
- ASTRID LIEVRE
- Contact Person Email
- astrid.lievre@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Chirurgie Digestive
- Principal Investigator Name
- Jean-Marc Regimbeau
- Principal Investigator Email
- regimbeau.jean-marc@chu-amiens.fr
- Contact Person Name
- Jean-Marc Regimbeau
- Contact Person Email
- regimbeau.jean-marc@chu-amiens.fr
- Site Name
- University Hospital Of Montpellier
- Department Name
- chirugie Digestive et oncologique
- Principal Investigator Name
- François QUENET
- Principal Investigator Email
- Francois.Quenet@icm.unicancer.fr
- Contact Person Name
- François QUENET
- Contact Person Email
- Francois.Quenet@icm.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- chirurgie viscérale et Digestive
- Principal Investigator Name
- Olivier FACY
- Principal Investigator Email
- olivier.dacy@chu.dijon.fr
- Contact Person Name
- Olivier FACY
- Contact Person Email
- olivier.dacy@chu.dijon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Chirugie Hépatobilliaire et digestive
- Principal Investigator Name
- STYLIANOS TZEDAKIS
- Principal Investigator Email
- stylianos.tzedakis@aphp.fr
- Contact Person Name
- STYLIANOS TZEDAKIS
- Contact Person Email
- stylianos.tzedakis@aphp.fr
- Site Name
- CHU De Rouen
- Department Name
- chirugie Digestive
- Principal Investigator Name
- Lilian SCHWARZ
- Principal Investigator Email
- lilian.schwarz@chu-rouen.fr
- Contact Person Name
- Lilian SCHWARZ
- Contact Person Email
- lilian.schwarz@chu-rouen.fr
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- chirugie Digestive et oncologique
- Principal Investigator Name
- Guillaume PASSOT
- Principal Investigator Email
- guillaume.passot@chu-lyon.fr
- Contact Person Name
- Guillaume PASSOT
- Contact Person Email
- guillaume.passot@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Chirugie Hépatobilliaire et transplantation
- Principal Investigator Name
- Laurent CHRISTOPHE
- Principal Investigator Email
- christophe.laurent@chu-bordeaux.fr
- Contact Person Name
- Laurent CHRISTOPHE
- Contact Person Email
- christophe.laurent@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Chirugie Hépatobilliaire et transplantation
- Principal Investigator Name
- Antonio Sa Cunha
- Principal Investigator Email
- antonio.sacunha@aphp.fr
- Contact Person Name
- Antonio Sa Cunha
- Contact Person Email
- antonio.sacunha@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- ONDANSETRON
- Active Substance
- ONDANSETRON
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 8 mg
- Investigational Product Name
- IRINOTECAN
- Active Substance
- IRINOTECAN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Maximum Dose
- 180 mg/m2
- Investigational Product Name
- CALCIUM FOLINATE
- Active Substance
- CALCIUM FOLINATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 400 mg/m2
- Investigational Product Name
- CALCIUM LEVOFOLINATE
- Active Substance
- CALCIUM LEVOFOLINATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 200 mg/m2
- Investigational Product Name
- FLUOROURACIL
- Active Substance
- FLUOROURACIL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- INTRAVENOUS BOLUS USE
- Maximum Dose
- 400 mg/m2
- Investigational Product Name
- METHYLPREDNISOLONE
- Active Substance
- METHYLPREDNISOLONE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 120 mg
- Combination Treatment
- Yes
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