Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment
CHIPOR
A Phase III Randomized Study Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer
2 other identifiers
interventional
415
3 countries
33
Brief Summary
CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2011
Longer than P75 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2011
CompletedStudy Start
First participant enrolled
April 26, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2027
ExpectedApril 23, 2025
April 1, 2025
11.7 years
March 28, 2011
April 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
overall survival
Follow-up of 4 years.
from randomization to death (up to 4 years)
Secondary Outcomes (1)
relapse free survival
from randomization to relapse (up to 4 years)
Study Arms (2)
maximal cytoreductive surgery without HIPEC
ACTIVE COMPARATORThe participant will have a regular cytoreductive surgery without the adjunction of HIPEC.
maximal cytoreductive surgery with HIPEC
EXPERIMENTALThe participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m²
Interventions
Maximal cytoreductive surgery
HIPEC: Hyperthermic Intra-PEritoneal Chemotherapy. Administration of cisplatin at 75mg/m²
Eligibility Criteria
You may qualify if:
- Patient age ≥ 18 years
- Performance Status WHO \< 2
- Initially treated for Epithelial Ovarian Carcinoma
- Patient with only peritoneal relapse occurred at least 6 month from the initial treatment, resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal)
- Platinum based second-line chemotherapy before surgery with either carboplatine-paclitaxel, or carboplatine-caelyx
- Complete cytoreductive surgery
- The surgery has to be planned 5 to 8 weeks from the last 2nd of chemotherapy
- No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
- No Renal insufficiency (serum creatinine \< 1,5 time the normal limit, creatinine clearance \> 80 mL/min). calculated with MDRD method
- Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
- No contraindication to general anaesthesia for heavy surgery
- Patients having read, signed and dated Informed consent before any study procedure
- Childbearing patients have to take appropriate contraceptive methods during the treatment and until 6 months after the treatment
You may not qualify if:
- Patient age \<18 years
- Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma)
- Hypersensitivity to Platinum compound
- Distant metastasis
- Use of anti-angiogenic treatment
- Patient with other concurrent severe life threatening disease
- The need to perform more than two segmental digestive resections during the CRS +/- HIPEC surgery
- Any progressive disease during the IV systemic second-line chemotherapy (platine-based)
- Incomplete cytoreductive surgery with macroscopical residual disease (Sugarbaker \> CC1)
- Early relapse: less than 6 mois after the end of the first treatment
- Ovarian tumor other than Epithelioma Ovarian Cancer
- Uncontrolled infection
- Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Clinically significant cardiovascular disease contraindicating the hyper hydratation, which is necessary for HIPEC
- Patient already treated with HIPEC for the ovarian cancer
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (33)
Institut Jules Bordet
Brussels, Belgium
CHU d'AMIENS
Amiens, France
Centre Paul Papin
Angers, 49933, France
Institut Bergonie
Bordeaux, 33076, France
Clinique Pasteur
Brest, France
Polyclinique Kéraudren
Brest, France
Centre Francois Baclesse
Caen, 14076, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre hospitalier de Dijon
Dijon, France
CHU de Grenoble
Grenoble, France
Clinique Victor Hugo
Le Mans, France
Pôle Santé Sud
Le Mans, France
Centre Oscar Lambret
Lille, 59020, France
CHU de Lille
Lille, France
Centre Hospitalier Universitaire Dupuytren
Limoges, 87042, France
Centre Leon Berard
Lyon, 69373, France
Centre Hopsitalier Lyon Sud
Lyon, 69495, France
Institut Paoli Calmettes
Marseille, 13273, France
AP-HM - Hôpital de la Timone
Marseille, France
CRLC Val d'Aurelle
Montpellier, 34298, France
Centre Hospitalier Universitaire Nice
Nice, 06202, France
Hopital Lariboisiere
Paris, 75010, France
Hopital Tenon
Paris, 75020, France
Hôpital Européen Georges Pompidou
Paris, France
Institut Curie
Paris, France
CHU - Hôpital de la Milétrie
Poitiers, France
Centre Hospitalier Universitaire Saint Etienne- Hopital Nord
Saint-Etienne, 42055, France
Ico-Centre Rene Gauducheau
Saint-Herblain, 44805, France
CHU Hautepierre
Strasbourg, 67098, France
Institut Claudius Regaud
Toulouse, 31052, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
Institut Gustave Roussy
Villejuif, 94805, France
Hospital Universitari Germans Trias I Pujol
Badalona, Spain
Related Publications (3)
Brigand C, Monneuse O, Mohamed F, Sayag-Beaujard AC, Isaac S, Gilly FN, Glehen O. Peritoneal mesothelioma treated by cytoreductive surgery and intraperitoneal hyperthermic chemotherapy: results of a prospective study. Ann Surg Oncol. 2006 Mar;13(3):405-12. doi: 10.1245/ASO.2006.05.041. Epub 2006 Jan 30.
PMID: 16485159RESULTArmstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
PMID: 16394300RESULTClasse JM, Meeus P, Hudry D, Wernert R, Quenet F, Marchal F, Houvenaeghel G, Bats AS, Lecuru F, Ferron G, Brigand C, Berton D, Gladieff L, Joly F, Ray-Coquard I, Durand-Fontanier S, Liberale G, Pocard M, Georgeac C, Gouy S, Guilloit JM, Guyon F, Costan C, Rousselet JM, de Guerke L, Bakrin N, Brument E, Martin E, Asselain B, Campion L, Glehen O; UNICANCER/CHIPOR Investigators. Hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer (CHIPOR): a randomised, open-label, phase 3 trial. Lancet Oncol. 2024 Dec;25(12):1551-1562. doi: 10.1016/S1470-2045(24)00531-X. Epub 2024 Nov 14.
PMID: 39549720DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Marc CLASSE
Centre rené Gauducheau, NANTES
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2011
First Posted
June 20, 2011
Study Start
April 26, 2011
Primary Completion
January 8, 2023
Study Completion (Estimated)
May 14, 2027
Last Updated
April 23, 2025
Record last verified: 2025-04