A study researching the effect of upfront cytoreductive surgery with or without intraperitoneal lavage under heated conditions (HIPEC) in subjects with stage III ovarian cancer - OVHIPEC-2
Phase 3
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/08/056165
- Lead Sponsor
- Antoni Van Leeuwenhoek Netherlands Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Candidate for primary CRS
2. Histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer
Exclusion Criteria
1.History of previous malignancies within 5 years prior to inclusion
2.FIGO stage IV disease
3.Complete primary cytoreduction is impossible
4.Prior treatment for the current malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective of this study is to prove the beneficial effect of complete or near-complete (residual disease â?¤2.5 mm) primary cytoreductive surgery (CRS) in combination with HIPEC (treatment arm) resulting in improved outcome compared to primary cytoreductive surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage III epithelial ovarian cancer.The primary outcome is overall survival, defined as the time from randomization to the date of death from any cause.Timepoint: For subjects that are alive, their survival time will be censored at the date of last contact (â??last known alive date ?). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up.
- Secondary Outcome Measures
Name Time Method Adverse events: <br/ ><br>toxicity of extra treatment compared standaard treatmentTimepoint: 30 days after end of treatment;Cost evaluation: <br/ ><br>cost evaluation based measured by quality adjusted life year <br/ ><br>Timepoint: 1 year after lplv;Recurrence-free survivalTimepoint: 1 year after last patient last visit