Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment

NCT ID: NCT01376752

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-26
• Study Completion Date: 2027-05-14

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.

Detailed Description

The patient received before the surgery a second line chemotherapy, platinum-based regimen with either carboplatine-paclitaxel, or carboplatine-caelyx. At the end of the six courses IV chemotherapy, if the disease is still responding and if a complete cytoreductive surgery seems possible, the patient is included after signed informed consent and will be operated 5 to 8 weeks after the last second-line chemotherapy cycle.

So, during the surgery the patient will be randomized if the complete cytoreductive surgery is really done and will then receive:

• either treatment A = maximal cytoreductive surgery without HIPEC
• or treatment B = maximal cytoreductive surgery with HIPEC

The HIPEC will be done at the end of the surgery. At the end of cytoreductive surgery, tumor residual disease must be null or very limited (Sugarbaker completeness cytoreduction: CC0 (no residual)-CC1 (residual < 0.25cm).

Two methods will be used for the HIPEC: Open or closed abdomen, depends on the site practice. Each site will use the same method during the study for all included patients.

Conditions

Ovarian Epithelial Cancer Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

maximal cytoreductive surgery without HIPEC

The participant will have a regular cytoreductive surgery without the adjunction of HIPEC.

Group Type: ACTIVE_COMPARATOR

Maximal cytoreductive surgery

Intervention Type: PROCEDURE

Maximal cytoreductive surgery

maximal cytoreductive surgery with HIPEC

The participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m²

Group Type: EXPERIMENTAL

Maximal cytoreductive surgery

Intervention Type: PROCEDURE

Maximal cytoreductive surgery

HIPEC

Intervention Type: DRUG

HIPEC: Hyperthermic Intra-PEritoneal Chemotherapy. Administration of cisplatin at 75mg/m²

Interventions

Maximal cytoreductive surgery

Maximal cytoreductive surgery

Intervention Type: PROCEDURE

HIPEC

HIPEC: Hyperthermic Intra-PEritoneal Chemotherapy. Administration of cisplatin at 75mg/m²

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Individual deprived of liberty or placed under the authority of a tutor

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Marc CLASSE

Role: PRINCIPAL_INVESTIGATOR

Centre rené Gauducheau, NANTES

Locations

Institut Jules Bordet

Brussels, , Belgium

CHU d'AMIENS

Amiens, , France

Centre Paul Papin

Angers, , France

Institut Bergonie

Bordeaux, , France

Clinique Pasteur

Brest, , France

Polyclinique Kéraudren

Brest, , France

Centre Francois Baclesse

Caen, , France

Centre Jean Perrin

Clermont-Ferrand, , 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, , France

CHU de Lille

Lille, , France

Centre Hospitalier Universitaire Dupuytren

Limoges, , France

Centre Leon Berard

Lyon, , France

Centre Hopsitalier Lyon Sud

Lyon, , France

Institut Paoli Calmettes

Marseille, , France

AP-HM - Hôpital de la Timone

Marseille, , France

CRLC Val d'Aurelle

Montpellier, , France

Centre Hospitalier Universitaire Nice

Nice, , France

Hopital Lariboisiere

Paris, , France

Hopital Tenon

Paris, , 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, , France

Ico-Centre Rene Gauducheau

Saint-Herblain, , France

CHU Hautepierre

Strasbourg, , France

Institut Claudius Regaud

Toulouse, , France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Institut Gustave Roussy

Villejuif, , France

Hospital Universitari Germans Trias I Pujol

Badalona, , Spain

Countries

Belgium; France; Spain

References

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.

Reference Type: RESULT

PMID: 16485159 (View on PubMed)

Armstrong 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.

Reference Type: RESULT

PMID: 16394300 (View on PubMed)

Classe 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.

Reference Type: DERIVED

PMID: 39549720 (View on PubMed)

Other Identifiers

2010-023035-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FEDEGYN 02 / 0410-CHIPOR

Identifier Type: -

Identifier Source: org_study_id