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

NCT01376752 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 415

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Ovarian Epithelial Cancer Recurrent

Interventions

PROCEDURE

Maximal cytoreductive surgery

Maximal cytoreductive surgery

DRUG

HIPEC

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

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Jean-Marc CLASSE · Centre rené Gauducheau, NANTES

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-26
Primary Completion
2023-01-08
Completion
2027-05-14

Countries

  • Belgium
  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01376752 on ClinicalTrials.gov