Status:
RECRUITING
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI)
Lead Sponsor:
Centre Oscar Lambret
Conditions:
Ovary Neoplasms
Ovarian Cancer
Eligibility:
FEMALE
18-76 years
Phase:
PHASE3
Brief 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) o...
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 ...
Eligibility Criteria
Inclusion
- Pre-eligibility criteria to be checked before surgery for pre-registration
- 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
- 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
- Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) (≤5.0 × ULN in case of liver metastases)
- Total bilirubin ≤1.5 × ULN (except in case of Gilbert's disease)
- Creatinine clearance ≥ 60 mL/ min
- Negative serum pregnancy test within 7 days prior to surgery for women of childbearing potential. For non-menopausal women, if no hysterectomy is planned, willing to accept the use of an effective contraceptive regimen during the treatment period and at least 6 months after the end of treatment (surgery or adjuvant chemotherapy)
- Absence of contraindication to receive the products used in this study (cisplatin and products used in neo-adjuvant/ adjuvant chemotherapy) according to the most recent SmPC (Summary of Product Characteristics) of these products
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up
- Signed written informed consent
- Patient covered by the French or Belgian "Social Security" regime Criteria to be checked per-operatively for confirmation of enrolment and randomization
- Residual disease after surgery (cytoreduction score CC) CC-0 (no macroscopic residue) or CC-1 (residue \< 2.5 mm)
- Per-operative hemorrhage \< 2.5 L
- Strictly less than 3 digestive resections performed during surgery
- Diuresis maintained during surgery, without oliguria or anuria (per-operatory diuresis ≥ 0,5 mL/ kg/ h)
Exclusion
- Benign disease, borderline disease, non epithelial ovarian carcinoma or carcinosarcoma
- Cirrhosis
- 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
- Receipt of live attenuated vaccine, including yellow fever vaccine, within 30 days prior to inclusion (and, if patient is enrolled, up to 30 days after the last administration of study treatment)
- Pregnant or breastfeeding woman
- Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent
- Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
- Person under guardianship
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT03842982
Start Date
April 1 2019
End Date
November 1 2026
Last Update
September 22 2025
Active Locations (18)
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1
Institut Jules Bordet
Brussels, Belgium, 1070
2
Cliniques universitaires St-Luc, Institut Roi Albert II
Brussels, Belgium, 1200
3
Institut de Cancérologie de l'Ouest
Angers, France, 49055
4
Institut Bergonié
Bordeaux, France, 33076