Epithelial ovarian cancer, Fallopian tube ovarian cancer, Peritoneal ovarian cancer MedDRA version: 20.0 Level: LLT Classification code 10033131 Term: Ovarian carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classifica
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: CISPLATIN
CAS Number: 15663-27-1
Current Sponsor code: CISPLATIN
Other descriptive name: CISPLATIN
Concentration unit: g/ml gram(s)/millilitre
Concentration
Sponsors
Centre Oscar Lambret
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pre-eligibility criteria to be checked before surgery for pre-registration 1. Age =18 years and = 76 years 2. 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) 3. FIGO stage III 4. Patient eligible for a. Primary Debulking Surgery (PDS) with planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy b. 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. 5. WHO Performance Status = 2 6. Physical status score ASA = 2 7. Adequate bone marrow and renal function, as evidenced by the following tests performed within 7 days prior to surgery: - Absolute Neutrophil Count (ANC) =1,500/mm3 - Platelets =100,000/mm3 - Creatinine clearance = 60 mL/ min 8. Signed, IRB-approved written informed consent 9. Patient covered by the French or Belgian “Social Security” regime Criteria to be checked per-operatively for confirmation of enrolment and randomization 10. Residual disease after surgery CC-0 (no macroscopic residue) or CC-1 (residue =65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: - Carcinosarcoma - Cirrhosis - Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation - Pregnant or breastfeeding woman - Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons) - Person under guardianship or curatorship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: DFS will be computed as the time interval between randomization and progression, relapse or death from any cause. Progression and relapses will be confirmed by the local tumor board, based on GCIC criteria. For patients alive without progression or relapse, data will be censored at the date of last follow-up visit.;Main Objective: 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 Objective: 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 Other exploratory objectives 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 ;Primary end point(s): Disease-free survival (DFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: 1) Overall survival OS will be computed as the time interval between randomization and death from any cause. For patients alive, data will be censored at the date of last follow-up. 2) Adverse events Adverse events will be evaluated according to NCI-CTCAE V5.0 over the whole treatment duration plus 60 days, excluding AE unequivocally related to the disease under study or its progression. Adverse events of grade 3 or more (grade 3+) will be counted as severe adverse events. 3) Quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) computed from survival times (overall survival and progression-free survival) and adverse events data (date of occurrence of grade 3+ adverse event classified as drug-related) as detailed in the statistical considerations. 4) Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Score 30 (QLQ-C30), and Quality of Life Questionnaire–Ovarian Cancer Module (QLQ-OV28) Exploratory endpoints: 1) Count of residual viable cells (evaluated by flow cytometry) in abdominal drainage fluids 2) Further researches on the constituted biobank (tumoral samples and blood samples) could be performed if additional and specific funding is obtained. ;Timepoint(s) of evaluation of this end point: Between randomisation and the eventual progression, relapse of the disease or death. | — |
Countries
Belgium, France
Contacts
Public ContactDRCI Sponsor unit
Centre Oscar Lambret
Outcome results
None listed