Clinical trial • Phase III • Oncology|Gastroenterology
INDOCYANINE GREEN for Colorectal cancer
Phase III trial of INDOCYANINE GREEN for Colorectal cancer. Randomised. 1010 participants.
Overview
- Trial Therapeutic Area
- Oncology|Gastroenterology
- Trial Disease
- Colorectal cancer
- Trial Stage
- Phase III
- Drug Modality
- Diagnostic agent
Key dates
- Initial CTIS Submission Date
- 19-08-2024
- First CTIS Authorization Date
- 10-09-2024
Trial design
Randomised Phase III trial across 34 sites in France.
- Randomised
- Yes
- Target Sample Size
- 1010
- Trial Duration For Participant
- 90
Eligibility
Recruits 1010 Protected adults (individuals under guardianship by court order) are excluded; participation requires signed informed consent; refusal or inability to provide informed consent excludes participation..
- Pregnancy Exclusion
- Pregnant patients
- Vulnerable Population
- Protected adults (individuals under guardianship by court order) are excluded; participation requires signed informed consent; refusal or inability to provide informed consent excludes participation.
Inclusion criteria
- {"criterion_text":"- Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis."}
- {"criterion_text":"- Signed informed consent"}
- {"criterion_text":"- Affiliated to the French social security system (CMU included)."}
- {"criterion_text":"- Adult patients (age >18 years)"}
Exclusion criteria
- {"criterion_text":"- Emergent surgery"}
- {"criterion_text":"- Inflammatory bowel disease"}
- {"criterion_text":"- History of known allergy to indocyanine"}
- {"criterion_text":"- Pregnant patients"}
- {"criterion_text":"- Refusal to participate or inability to provide informed consent"}
- {"criterion_text":"- Protected adults (individuals under guardianship by court order)."}
- {"criterion_text":"- Rectal cancer requiring total mesorectal excision and anastomosis below the peritoneal reflexion"}
- {"criterion_text":"- Colon cancer requiring total or subtotal colectomy defined as a right colectomy extended to the splenic flexure or more)"}
- {"criterion_text":"- Colon cancer requiring transverse colectomy"}
- {"criterion_text":"- Recurrent colorectal cancer"}
- {"criterion_text":"- Locally advanced colorectal cancer requiring multi-visceral excision"}
- {"criterion_text":"- History of colectomy"}
- {"criterion_text":"- Associated concomitant resection of other organ (liver, etc.)"}
- {"criterion_text":"- Previous pelvic radiotherapy for pathology unrelated to diagnosis with colon cancer e.g. treatment for prostate cancer"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the occurrence of an anastomotic leakage 90-days post-operation. Anastomotic leakage is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer","definition_or_measurement_approach":"Occurrence of anastomotic leakage within 90 days post-operation; defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed on imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer."}
Secondary endpoints
- {"endpoint_text":"- Change in planned anastomosis during surgery defined as any decision change upon perfusion assessment such as modifying the initially planned transection level of the descending colon or refashioning anastomosis including the decision to undertake a permanent stoma rather than an anastomosis","definition_or_measurement_approach":"Defined as any intraoperative decision change following perfusion assessment (examples: modifying transection level, refashioning anastomosis, or deciding on permanent stoma instead of anastomosis)."}
- {"endpoint_text":"- Rate of defunctioning stoma","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall 90-day postoperative morbidity, including all complications according to the Clavien-Dindo classification, and occurring within 90 days after surgery","definition_or_measurement_approach":"All complications occurring within 90 days after surgery, classified according to the Clavien-Dindo classification."}
- {"endpoint_text":"- Postoperative mortality, including all deaths occurring within 90 days after surgery","definition_or_measurement_approach":"All-cause mortality within 90 days after surgery."}
- {"endpoint_text":"- Duration of hospital stay, calculated from the day of surgery to the day of hospital discharge","definition_or_measurement_approach":"Calculated as number of days from day of surgery to day of hospital discharge."}
- {"endpoint_text":"- Postoperative reintervention within 90 days","definition_or_measurement_approach":"Any surgical or interventional reoperation/intervention occurring within 90 days post-operation."}
- {"endpoint_text":"- HRQoL using the QLQ-C30 and QLQ-CR29 at baseline and 90 days post-operation","definition_or_measurement_approach":"Health-related quality of life measured using EORTC QLQ-C30 and QLQ-CR29 instruments at baseline and at 90 days post-operation."}
- {"endpoint_text":"- Medico-economic interest of IOFA with ICG use","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 1010
- Recruitment Window Months
- 63
- Consent Approach
- Participation requires signed informed consent (Subject information and informed consent form available as a document). Refusal or inability to provide informed consent excludes the subject. Protected adults under guardianship are excluded. No paediatric/assent processes are indicated.
Geography
- Total Number Of Sites
- 34
- Total Number Of Participants
- 1010
France
- Earliest CTIS Part Ii Submission Date
- 02-09-2024
- Latest Decision Or Authorization Date
- 15-01-2026
- Processing Time Days
- 500
- Number Of Sites
- 34
- Number Of Participants
- 1010
Sites
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Benoit ROMAIN
- Principal Investigator Email
- benoit.romain@chru-strasbourg.fr
- Contact Person Name
- Benoit ROMAIN
- Contact Person Email
- benoit.romain@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Chirurgie Digestive et Oncologique
- Principal Investigator Name
- Gilles MANCEAU
- Principal Investigator Email
- gilles.manceau@aphp.fr
- Contact Person Name
- Gilles MANCEAU
- Contact Person Email
- gilles.manceau@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- chirurgie digestive
- Principal Investigator Name
- Etienne BUSCAIL
- Principal Investigator Email
- ebuscail@me.com
- Contact Person Name
- Etienne BUSCAIL
- Contact Person Email
- ebuscail@me.com
- Site Name
- CHU Besancon
- Department Name
- Chirurgie digestive
- 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
- Institut Gustave Roussy
- Department Name
- chirurgie viscérale
- Principal Investigator Name
- Léonor Benhaim
- Principal Investigator Email
- leonor.benhaim@gustaveroussy.fr
- Contact Person Name
- Léonor Benhaim
- Contact Person Email
- leonor.benhaim@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Bertrand TRILLING
- Principal Investigator Email
- BTrilling@chu-grenoble.fr
- Contact Person Name
- Bertrand TRILLING
- Contact Person Email
- BTrilling@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Chirurgie générale et digestive
- Principal Investigator Name
- Nathan MORENO-LOPEZ
- Principal Investigator Email
- nathan.moreno-lopez@chu-dijon.fr
- Contact Person Name
- Nathan MORENO-LOPEZ
- Contact Person Email
- nathan.moreno-lopez@chu-dijon.fr
- Site Name
- Centre Hospitalier Annecy Genevois
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Olivier OULIE
- Principal Investigator Email
- ooulie@ch-annecygenevois.fr
- Contact Person Name
- Olivier OULIE
- Contact Person Email
- ooulie@ch-annecygenevois.fr
- Site Name
- Centre Hospitalier William Morey
- Department Name
- Chirurgie digestive et oncologique
- Principal Investigator Name
- Jeanne CAILLOT
- Principal Investigator Email
- jeanne.caillot@ch-chalon71.fr
- Contact Person Name
- Jeanne CAILLOT
- Contact Person Email
- jeanne.caillot@ch-chalon71.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- chirurgie digestive
- 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 De Marseille
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Diane MEGE
- Principal Investigator Email
- diane.mege@ap-hm.fr
- Contact Person Name
- Diane MEGE
- Contact Person Email
- diane.mege@ap-hm.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Chirurgie Viscérale et Digestive
- 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 Regional Universitaire De Tours
- Department Name
- chirurgie digestive
- Principal Investigator Name
- Mehdi OUAÏSSI
- Principal Investigator Email
- m.ouaissi@chu-tours.fr
- Contact Person Name
- Mehdi OUAÏSSI
- Contact Person Email
- m.ouaissi@chu-tours.fr
- Site Name
- Clinique Tivoli Ducos
- Department Name
- Chirurgie Digestive
- 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 De Lille
- Department Name
- Chirurgie digestive
- 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
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Véronique DESFOURNEAUX
- Principal Investigator Email
- veronique.desfourneaux@chu-rennes.fr
- Contact Person Name
- Véronique DESFOURNEAUX
- Contact Person Email
- veronique.desfourneaux@chu-rennes.fr
- Site Name
- Hopital Europeen Marseille
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Régis FARA
- Principal Investigator Email
- r.fara@hopital-europeen.fr
- Contact Person Name
- Régis FARA
- Contact Person Email
- r.fara@hopital-europeen.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- chirurgie idgestive
- Principal Investigator Name
- David ORRY
- Principal Investigator Email
- dorry@cgfl.fr
- Contact Person Name
- David ORRY
- Contact Person Email
- dorry@cgfl.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Chirurgie viscérale et digestive
- 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
- Hospices Civils De Lyon
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Eddy COTTE
- Principal Investigator Email
- eddy.cotte@chu-lyon.fr
- Contact Person Name
- Eddy COTTE
- Contact Person Email
- eddy.cotte@chu-lyon.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Mehrdad JAFARI
- Principal Investigator Email
- m-jafari@o-lambret.fr
- Contact Person Name
- Mehrdad JAFARI
- Contact Person Email
- m-jafari@o-lambret.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- chirurgie digestive
- Principal Investigator Name
- Koceila Amine AMROUN
- Principal Investigator Email
- lamroun@chu-reims.fr
- Contact Person Name
- Koceila Amine AMROUN
- Contact Person Email
- lamroun@chu-reims.fr
- Site Name
- Institut De Cancerologie De Lorraine
- Department Name
- chirurgie digestive
- 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 Paoli Calmettes
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Cécile DE CHAISEMARTIN
- Principal Investigator Email
- dechaisemartinc@ipc.unicancer.fr
- Contact Person Name
- Cécile DE CHAISEMARTIN
- Contact Person Email
- dechaisemartinc@ipc.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- chirurgie digestive
- Principal Investigator Name
- Jérémie LEFEVRE
- Principal Investigator Email
- mahaut.leconte@cch.aphp.fr
- Contact Person Name
- Jérémie LEFEVRE
- Contact Person Email
- mahaut.leconte@cch.aphp.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Chirurgie digstive
- 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
- Sante Atlantique
- Department Name
- chirurgie digestive
- Principal Investigator Name
- Antoine SINA
- Principal Investigator Email
- antoine.sina@elsan.care
- Contact Person Name
- Antoine SINA
- Contact Person Email
- antoine.sina@elsan.care
- Site Name
- Clinique De La Sauvegarde
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Benoît GIGNOUX
- Principal Investigator Email
- gignoux@chirurgien-digestif.com
- Contact Person Name
- Benoît GIGNOUX
- Contact Person Email
- gignoux@chirurgien-digestif.com
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- chirurgie digestive
- Principal Investigator Name
- Gilles MANCEAU
- Principal Investigator Email
- gilles.manceau@aphp.fr
- Contact Person Name
- Gilles MANCEAU
- Contact Person Email
- gilles.manceau@aphp.fr
- Site Name
- Hopital Saint Joseph
- Department Name
- chirurgie digestive
- Principal Investigator Name
- Caroline ROSSI
- Principal Investigator Email
- carossi@hopital-saint-joseph.fr
- Contact Person Name
- Caroline ROSSI
- Contact Person Email
- carossi@hopital-saint-joseph.fr
- Site Name
- Hopital NOVO
- Department Name
- chirurgie digestive
- Principal Investigator Name
- Nelson TRELLES
- Principal Investigator Email
- nelson.trelles@ght-novo.fr
- Contact Person Name
- Nelson TRELLES
- Contact Person Email
- nelson.trelles@ght-novo.fr
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Department Name
- chirurgie digestive
- Principal Investigator Name
- Jérôme LORIAU
- Principal Investigator Email
- jloriau@ghpsj.fr
- Contact Person Name
- Jérôme LORIAU
- Contact Person Email
- jloriau@ghpsj.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Chirurgie digestive
- Principal Investigator Name
- Mahaut LECONTE
- Principal Investigator Email
- mahaut.leconte@cch.aphp.fr
- Contact Person Name
- Mahaut LECONTE
- Contact Person Email
- mahaut.leconte@cch.aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Chirurgie Digestive Oncologique
- Principal Investigator Name
- Léon MAGGIORI
- Principal Investigator Email
- leon.maggiori@aphp.fr
- Contact Person Name
- Léon MAGGIORI
- Contact Person Email
- leon.maggiori@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Regional Universitaire
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- INFRACYANINE 25 mg/10 mL, poudre et solvant pour solution injectable
- Active Substance
- INDOCYANINE GREEN
- Modality
- Diagnostic agent
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- Intravenous bolus
- Authorisation Status
- Marketing authorisation: 34009 360 841 7 9 (France)
- Starting Dose
- 0.2 mg/kg
- Maximum Dose
- 0.2 mg/kg
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