Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI) (NCT03842982) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI)
Belgium, France362 participantsStarted 2019-05-03
Plain-language 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.
Who can participate
Age range18 Years – 76 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years and ≤ 76 years
✓. Histologically proven primary epithelial ovarian carcinoma or fallopian tube carcinoma or peritoneal carcinoma (including serous papillary adenocarcinoma, clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma)
✓. Pre-therapeutic FIGO (International Federation of Gynecology and Obstetrics) stage III
✓. Patient eligible for
✓. Primary Debulking Surgery (PDS) with planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy
✓. Or Interval Debulking Surgery (IDS) after neo-adjuvant chemotherapy +/- bevacizumab or other targeted therapy, with or without planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy. In case of neo-adjuvant chemotherapy, surgery should be performed in a time interval of 3 to 5 weeks in case of chemotherapy without bevacizumab, and in a time interval of 4 to 6 weeks if chemotherapy is combined with bevacizumab. The patient remains eligible for the study if surgery is delayed beyond the recommended time interval.
✓. WHO (World Health Organization Performance Status) ≤ 2
✓. Physical status score ASA (American Society of Anesthesiologists) ≤ 2
Exclusion criteria
✕. Benign disease, borderline disease, non epithelial ovarian carcinoma or carcinosarcoma
✕. Cirrhosis
✕
What they're measuring
1
Disease-free Survival (DFS)
Timeframe: From randomization to first progression, relapse or death from any cause, whichever came first, assessed up to 5 years. (Follow-up up to 5 years)
. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
✕. Auditory impairment
✕. Dehydration or intercurrent disease that contraindicates hyperhydration (including cardio-respiratory disease)
✕. Other uncontrolled intercurrent disease including, but not limited to: diabetes; hypertension; symptomatic congestive heart or pulmonary failure; renal, hepatic or severe gastrointestinal (associated with diarrhea) chronic disease
✕. Any unresolved NCI-CTCAE Grade ≥ 2 toxicity from previous anticancer therapy (excluding alopecia)
✕. Concomitant treatment with prophylactic phenytoin