Clinical trial • Phase III • Oncology|Gastroenterology
IRINOTECAN HYDROCHLORIDE for Locally advanced resectable rectal cancer
Phase III trial of IRINOTECAN HYDROCHLORIDE for Locally advanced resectable rectal cancer.
Overview
- Trial Therapeutic Area
- Oncology|Gastroenterology
- Trial Disease
- Locally advanced resectable rectal cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 05-04-2024
- First CTIS Authorization Date
- 21-05-2024
Trial design
Randomised, two arms: arm a: preoperative chemotherapy only. arm b: chemotherapy followed by chemoradiotherapy (pelvic irradiation). chemotherapy agents listed in trial documents include irinotecan, oxaliplatin, fluorouracil and calcium folinate; specific arm regimens/doses/schedules not detailed in provided record.-controlled Phase III trial across 46 sites in France.
- Randomised
- Yes
- Comparator
- Two arms: Arm A: preoperative chemotherapy only. Arm B: chemotherapy followed by chemoradiotherapy (pelvic irradiation). Chemotherapy agents listed in trial documents include irinotecan, oxaliplatin, fluorouracil and calcium folinate; specific arm regimens/doses/schedules not detailed in provided record.
- Target Sample Size
- 540
- Trial Duration For Participant
- 1095
Eligibility
Recruits 540 Protected adults are excluded (listed under exclusion criteria). Informed consent must be signed; participants must be 18 years or older. No paediatric/assent procedures described and isVulnerablePopulationSelected is false..
- Pregnancy Exclusion
- Pregnancy or breastfeeding
- Vulnerable Population
- Protected adults are excluded (listed under exclusion criteria). Informed consent must be signed; participants must be 18 years or older. No paediatric/assent procedures described and isVulnerablePopulationSelected is false.
Inclusion criteria
- {"criterion_text":"- Histologically proven middle or low rectal carcinoma, ≤ 12 cm from the anal verge on MRI (sagittal slide)\n- cT3N0 and/or cT1-T3N+ on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound)\n- Pretreatment predictive circumferential margin > 2mm on pretreatment imaging work up (pelvic contrast enhanced MRI)\n- Patients must be 18 years old or older\n- A World Health Organization (WHO/ECOG) performance status of 0 or 1\n- Informed consent signed\n- Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 6 months after the last study treatment"}
Exclusion criteria
- {"criterion_text":"- Rectal tumor > 12 cm from the anal verge on MRI (sagittal slide)\n- Contraindication to irinotecan : inflammatory bowel disease, bilirubin serum level > 3 times the upper limit of the normal rate, severe bone marrow insufficiency, WHO/ECOG performence status > 2\n- Concomitant treatment with millepertuis\n- Contraindication to oxaliplatin : bone marrow insufficiency before treatment initiation (neutrophil count <2x109/L and/or platelet count <100x109/L), peripheral neuropathy with permanent invalidity before treatment initiation\n- Contraindications to folinic acid : Biermer anemia and other anemia related to B12 vitamin insufficiency\n- Contraindications to capecitabine : severe renal insufficiency (Creatinin clearance <30 ml/min), complete and permanent insufficiency in dihydropyrimidine dehydrogenase\n- Live attenuated vaccine should not be used during and 6 months after preoperative treatment\n- Previous colorectal cancer\n- Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years\n- Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n- Protected adults\n- cT4 tumor on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound) or involvement of external sphincter\n- Pregnancy or breastfeeding\n- Patient with no national health or universal plan affiliation coverage\n- Circumferential margin ≤ 2 mm on pretreatment imaging work up (pelvic contrast enhanced MRI)\n- Metastatic disease\n- Prior pelvic irradiation or any contraindication to pelvic irradiation\n- Contraindication to oxaliplatin or irinotecan or 5FU based chemotherapy\n- Concomitant treatment with warfarin is contraindicated and warafarin must be replaced whenever possible to allow for inclusion\n- Recent or concomitant treatment with brivudine is contraindicated\n- Contraindications to 5-FU: complete and permanent insufficiency in dihydropyrimidine dehydrogenase, bone marrow insufficiency, chronic and severe infection"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The main endpoint of this phase III study is 3-year progression-free survival from the time to randomization.","definition_or_measurement_approach":"3-year progression-free survival measured from time of randomization (PFS at 3 years)."}
Recruitment
- Planned Sample Size
- 540
- Recruitment Window Months
- 138
- Consent Approach
- Informed consent must be signed by participant; participants must be 18 years or older. A subject information sheet and informed consent form for adults is provided (document L1_SIS and ICF adults). No assent/minor consent described; languages not specified.
Geography
- Total Number Of Sites
- 46
- Total Number Of Participants
- 540
France
- Earliest CTIS Part Ii Submission Date
- 12-03-2024
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 766
- Number Of Sites
- 46
- Number Of Participants
- 540
Sites
- Site Name
- Besancon University Hospital Center
- Department Name
- Oncologic and digestive surgery
- Principal Investigator Name
- Zaher LAKKIS
- Principal Investigator Email
- zlakkis@chu-besancon.fr
- Contact Person Name
- Zaher LAKKIS
- Contact Person Email
- zlakkis@chu-besancon.fr
- Site Name
- Groupement De Cooperation Sanitaire Risssa Recherche & Innovation Sante Sarcelles
- Department Name
- Radiotherapy
- Principal Investigator Name
- Anne LARROUY
- Principal Investigator Email
- a.larrouy@icpn.care
- Contact Person Name
- Anne LARROUY
- Contact Person Email
- a.larrouy@icpn.care
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Colorectal surgery
- Principal Investigator Name
- Massimo GIACCA
- Principal Investigator Email
- massimo.giacca@aphp.fr
- Contact Person Name
- Massimo GIACCA
- Contact Person Email
- massimo.giacca@aphp.fr
- Site Name
- IHFB Cognacq Jay
- Department Name
- Medical Oncology
- Principal Investigator Name
- Benoist Chibaudel CHIBAUDEL
- Principal Investigator Email
- benoist.chibaudel@ihfb.org
- Contact Person Name
- Benoist Chibaudel CHIBAUDEL
- Contact Person Email
- benoist.chibaudel@ihfb.org
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Digestive surgery
- Principal Investigator Name
- Uho MARCHESE
- Principal Investigator Email
- ugo.marchese@aphp.fr
- Contact Person Name
- Uho MARCHESE
- Contact Person Email
- ugo.marchese@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Digestive surgery
- Principal Investigator Name
- Géraldine PERKINS
- Principal Investigator Email
- geraldine.perkins@chu-rennes.fr
- Contact Person Name
- Géraldine PERKINS
- Contact Person Email
- geraldine.perkins@chu-rennes.fr
- Site Name
- Centre Hospitalier Simone Veil De Beauvais
- Department Name
- Digestive surgery
- Principal Investigator Name
- Francois MAUVAIS
- Principal Investigator Email
- rechercheclinique@ch-beauvais.fr
- Contact Person Name
- Francois MAUVAIS
- Contact Person Email
- rechercheclinique@ch-beauvais.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Radiation Oncology
- Principal Investigator Name
- Florence HUGUET
- Principal Investigator Email
- florence.huguet@aphp.fr
- Contact Person Name
- Florence HUGUET
- Contact Person Email
- florence.huguet@aphp.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncologic and digestive surgery
- Principal Investigator Name
- Leonor BENHAIM
- Principal Investigator Email
- leonor.benhaim@gustaveroussy.fr
- Contact Person Name
- Leonor BENHAIM
- Contact Person Email
- leonor.benhaim@gustaveroussy.fr
- Site Name
- Sainte Catherine Institut Du Cancer Avignon-Provence
- Department Name
- Radiation Oncology
- 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
- University Hospital Of Clermont-Ferrand
- Department Name
- Digestive surgery
- Principal Investigator Name
- Karine POIROT
- Principal Investigator Email
- kpoirot@chu-clermontferrand.fr
- Contact Person Name
- Karine POIROT
- Contact Person Email
- kpoirot@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Oncologic and digestive surgery
- Principal Investigator Name
- Sylvain MANFREDI
- Principal Investigator Email
- sylvain.manfredi@chu-dijon.fr
- Contact Person Name
- Sylvain MANFREDI
- Contact Person Email
- sylvain.manfredi@chu-dijon.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Digestive surgery
- 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
- Hopital Prive Jean Mermoz
- Department Name
- Digestive oncology
- 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
- Clinique Tivoli Ducos
- Department Name
- Digestive and parietal surgery
- Principal Investigator Name
- Quentin DENOST
- Principal Investigator Email
- q.denost@bordeaux-colorectal-institute.fr
- Contact Person Name
- Quentin DENOST
- Contact Person Email
- q.denost@bordeaux-colorectal-institute.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Digestive surgery
- Principal Investigator Name
- Jean-Luc FAUCHERON
- Principal Investigator Email
- jlfaucheron@chu-grenoble.fr
- Contact Person Name
- Jean-Luc FAUCHERON
- Contact Person Email
- jlfaucheron@chu-grenoble.fr
- Site Name
- CHRU De Nancy
- Department Name
- Digestive surgery
- Principal Investigator Name
- Adeline GERMAIN
- Principal Investigator Email
- a.germain@chru-nancy.fr
- Contact Person Name
- Adeline GERMAIN
- Contact Person Email
- a.germain@chru-nancy.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Surgical Oncology
- Principal Investigator Name
- Philippe ROUANET
- Principal Investigator Email
- philippe.rouanet@icm.unicancer.fr
- Contact Person Name
- Philippe ROUANET
- Contact Person Email
- philippe.rouanet@icm.unicancer.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Digestive oncology
- Principal Investigator Name
- Eric FRANCOIS
- Principal Investigator Email
- eric.francois@nice.unicancer.fr
- Contact Person Name
- Eric FRANCOIS
- Contact Person Email
- eric.francois@nice.unicancer.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- General and digestive surgery
- Principal Investigator Name
- Laura BEYER-BERJOT
- Principal Investigator Email
- laura.beyer@ap-hm.fr
- Contact Person Name
- Laura BEYER-BERJOT
- Contact Person Email
- laura.beyer@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Colorectal surgery
- Principal Investigator Name
- Benjamin FERNANDEZ
- Principal Investigator Email
- benjamin.fernandez@chu-bordeaux.fr
- Contact Person Name
- Benjamin FERNANDEZ
- Contact Person Email
- benjamin.fernandez@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- General and digestive surgery
- Principal Investigator Name
- Jérémie LEFEVRE
- Principal Investigator Email
- jeremie.lefevre@aphp.fr
- Contact Person Name
- Jérémie LEFEVRE
- Contact Person Email
- jeremie.lefevre@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncologic and digestive surgery
- Principal Investigator Name
- Frédérique PESCHAUD
- Principal Investigator Email
- frederique.peschaud@aphp.fr
- Contact Person Name
- Frédérique PESCHAUD
- Contact Person Email
- frederique.peschaud@aphp.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Surgical Oncology
- Principal Investigator Name
- Frédéric DUMONT
- Principal Investigator Email
- frederic.dumont@ico.unicancer.fr
- Contact Person Name
- Frédéric DUMONT
- Contact Person Email
- frederic.dumont@ico.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Surgical Oncology
- Principal Investigator Name
- Frédéric DUMONT
- Principal Investigator Email
- frederic.dumont@ico.unicancer.fr
- Contact Person Name
- Frédéric DUMONT
- Contact Person Email
- frederic.dumont@ico.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Digestive oncology
- Principal Investigator Name
- Sylvain MANFREDI
- Principal Investigator Email
- sylvain.manfredi@chu-dijon.fr
- Contact Person Name
- Sylvain MANFREDI
- Contact Person Email
- sylvain.manfredi@chu-dijon.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Digestive surgery
- Principal Investigator Name
- Benoît ROMAIN
- Principal Investigator Email
- benoit.romain@chru-strasbourg.fr
- Contact Person Name
- Benoît ROMAIN
- Contact Person Email
- benoit.romain@chru-strasbourg.fr
- Site Name
- Institut De Cancerologie De Lorraine
- Department Name
- Surgery
- Principal Investigator Name
- Cécilia CERIBELLI
- Principal Investigator Email
- c.ceribelli@nancy.unicancer.fr
- Contact Person Name
- Cécilia CERIBELLI
- Contact Person Email
- c.ceribelli@nancy.unicancer.fr
- Site Name
- Institut Mutualiste Montsouris
- Department Name
- Digestive surgery
- Principal Investigator Name
- Christine DENET
- Principal Investigator Email
- christine.denet@imm.fr
- Contact Person Name
- Christine DENET
- Contact Person Email
- christine.denet@imm.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Digestive surgery
- 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
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncologic and digestive surgery
- 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 Regional Universitaire De Tours
- Department Name
- General and digestive surgery
- Principal Investigator Name
- Mehdi OUAISSI
- Principal Investigator Email
- m.ouaissi@chu-tours.fr
- Contact Person Name
- Mehdi OUAISSI
- Contact Person Email
- m.ouaissi@chu-tours.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Radiotherapy
- Principal Investigator Name
- Mélanie DOS SANTOS
- Principal Investigator Email
- m.dossantos@baclesse.unicancer.fr
- Contact Person Name
- Mélanie DOS SANTOS
- Contact Person Email
- m.dossantos@baclesse.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Digestive surgery
- Principal Investigator Name
- Michel PRUDHOMME
- Principal Investigator Email
- drc@chu-nimes.fr
- Contact Person Name
- Michel PRUDHOMME
- Contact Person Email
- drc@chu-nimes.fr
- Site Name
- CHU De Rouen
- Department Name
- Digestive surgery
- Principal Investigator Name
- Jean-Jacques TUECH
- Principal Investigator Email
- jean-jacques.tuech@chu-rouen.fr
- Contact Person Name
- Jean-Jacques TUECH
- Contact Person Email
- jean-jacques.tuech@chu-rouen.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Digestive oncology
- Principal Investigator Name
- Julien TAIEB
- Principal Investigator Email
- julien.taieb@aphp.fr
- Contact Person Name
- Julien TAIEB
- Contact Person Email
- julien.taieb@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Digestive oncology
- 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
- Assistance Publique Hopitaux De Paris
- Department Name
- Digestive surgery
- 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
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Oncology radiotherapy
- Principal Investigator Name
- Pierre CLAVERE
- Principal Investigator Email
- pierre.clavere@unilim.fr
- Contact Person Name
- Pierre CLAVERE
- Contact Person Email
- pierre.clavere@unilim.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Oncologic and digestive surgery
- Principal Investigator Name
- Guillaume PIESSEN
- Principal Investigator Email
- guillaume.piessen@chru-lille.fr
- Contact Person Name
- Guillaume PIESSEN
- Contact Person Email
- guillaume.piessen@chru-lille.fr
- Site Name
- Institut Bergonie
- Department Name
- Oncologie digestive
- Principal Investigator Name
- Simon PERNOT
- Principal Investigator Email
- s.pernot@bordeaux
- Contact Person Name
- Simon PERNOT
- Contact Person Email
- s.pernot@bordeaux
- Site Name
- Institut Paoli Calmettes
- Department Name
- Digestive and surgical oncology
- Principal Investigator Name
- Bernard LELONG
- Principal Investigator Email
- elongb@ipc.unicancer.fr
- Contact Person Name
- Bernard LELONG
- Contact Person Email
- elongb@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Digestive surgery
- Principal Investigator Name
- Arnaud ALVES
- Principal Investigator Email
- alves-a@chu-caen.fr
- Contact Person Name
- Arnaud ALVES
- Contact Person Email
- alves-a@chu-caen.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Digestive surgery
- Principal Investigator Name
- Koceila LAMINE AMROUN
- Principal Investigator Email
- lkamroun@chu-reims.fr
- Contact Person Name
- Koceila LAMINE AMROUN
- Contact Person Email
- lkamroun@chu-reims.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologic and digestive surgery
- Principal Investigator Name
- Aurélien dupre
- Principal Investigator Email
- aurelien.dupre@lyon.unicancer.fr
- Contact Person Name
- Aurélien dupre
- Contact Person Email
- aurelien.dupre@lyon.unicancer.fr
- Site Name
- Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
- Department Name
- Digestive surgery and oncology
- Principal Investigator Name
- Jérôme LORIAU
- Principal Investigator Email
- jloriau@gmail.com
- Contact Person Name
- Jérôme LORIAU
- Contact Person Email
- jloriau@gmail.com
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
- IRINOTECAN
- Active Substance
- IRINOTECAN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Maximum Dose
- 180 mg/m2
- Investigational Product Name
- FLUOROURACIL
- Active Substance
- FLUOROURACIL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Maximum Dose
- 2400 mg/m2
- Investigational Product Name
- OXALIPLATIN
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Maximum Dose
- 85 mg/m2
- Investigational Product Name
- CALCIUM LEVOFOLINATE (PHF00231MIG)
- Active Substance
- CALCIUM FOLINATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Maximum Dose
- 200 mg/m2
- Investigational Product Name
- CALCIUM FOLINATE (PHF00190MIG)
- Active Substance
- CALCIUM FOLINATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Maximum Dose
- 400 mg/m2
- Combination Treatment
- Yes
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