drugset / Trial / NCT01376752

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

NCT01376752 ↗

Phase 3 Active not recruiting 415 enrolled UNICANCER
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Outcome

Met primary endpoint

paper Overall survival was significantly improved with HIPEC (stratified hazard ratio 0·73, 95% CI 0·56-0·96; p=0·024). PMID 39549720 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Other