NCT03842982

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI)

Phase III Randomized Clinical Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer Considering Two Different Settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 362 (estimated)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, multicenter, interventional and randomized study which evaluates the use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. This study aims to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC combined with standard care (PDS or IDS) or standard care alone.

Detailed description

The primary objective of this study is to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC treatment combined with standard care (PDS or IDS) or standard care alone (PDS or IDS alone). Secondary objectives of the study include: * Evaluating the efficacy of HIPEC in terms of overall survival (OS) in combination with standard of care * Evaluating the morbidity associated with HIPEC. * Evaluating the trade-off between efficacy and morbidity using the Q-TWiST approach. * Evaluating the impact of HIPEC in terms of quality of life. Exploratory objectives (optional) include: * Evaluating the impact of HIPEC on the count of residual viable cells (evaluated by flow cytometry) in abdominal drainage fluids for patients recruited in Centre Oscar Lambret only. * Constituting a biobank (tumoral samples and blood samples) for future translational researches

Conditions

• Ovary Neoplasms
• Ovarian Cancer
• Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	HIPEC	HIPEC protocol (ONLY Arm A) consisted in cisplatin 100mg/m2 intraperitoneally (IP), heated to 40°C for 90 minutes, along with an IV perfusion of sodium thiosulfate. Administration of the dose should be according the following schedule: * 50% of the dose at start of perfusion, 25% of the dose after 30 minutes from start of the perfusion and 25% of the dose after 60 minutes from start of the perfusion. * The procedure takes 120 minutes with a 90-minute perfusion period. The IV perfusion of sodium thiosulfate is for renal protection. At the start of HIPEC procedure, 9 g/m2 in 200 ml of distilled water will be administered by IV over 15 to 30 minutes. It will be then followed by 12 g/m2 in 1 liter (1L) distilled water in a continuous IV for 6 hours.

Timeline

• Start date: 2019-05-03
• Primary completion: 2031-02-01
• Completion: 2031-02-01
• First posted: 2019-02-15
• Last updated: 2026-03-16

Locations

18 sites across 2 countries: Belgium, France