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

Ovarian Epithelial Cancer Recurrent Clinical Trial

— CHIPOR  

Official title:

A Phase III Randomized Study Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01376752
• Other study ID #: FEDEGYN 02 / 0410-CHIPOR
• Secondary ID: 2010-023035-42
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 26, 2011
• Est. completion date: May 14, 2025

Study information

• Verified date: April 2024
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 415
• Est. completion date: May 14, 2025
• Est. primary completion date: January 8, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 = 1,5x10?/L, platelets = 100x10?/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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Epithelial Cancer Recurrent

Intervention

Procedure:
• Maximal cytoreductive surgery
Maximal cytoreductive surgery

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

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels
France	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 Hopsitalier Lyon Sud	Lyon
France	Centre Leon Berard	Lyon
France	AP-HM - Hôpital de la Timone	Marseille
France	Institut Paoli Calmettes	Marseille
France	CRLC Val d'Aurelle	Montpellier
France	Centre Hospitalier Universitaire Nice	Nice
France	Hôpital Européen Georges Pompidou	Paris
France	Hopital Lariboisiere	Paris
France	Hopital Tenon	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	Vandoeuvre-les-nancy
France	Institut Gustave Roussy	Villejuif
Spain	Hospital Universitari Germans Trias I Pujol	Badalona

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Countries where clinical trial is conducted

Belgium,  France,  Spain, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	Follow-up of 4 years.	from randomization to death (up to 4 years)
Secondary	relapse free survival	Follow-up of 4 years.	from randomization to relapse (up to 4 years)