Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI) (CHIPPI)
Ovary Neoplasms, Ovarian Cancer, Ovarian Carcinoma
About this trial
This is an interventional treatment trial for Ovary Neoplasms focused on measuring Ovarian cancer, Hyperthermic intraperitoneal chemotherapy, HIPEC, Primary Debulking Surgery, Interval Debulking Surgery
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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
Sites / Locations
- Cliniques universitaires St-Luc, Institut Roi Albert IIRecruiting
- Institut de Cancérologie de l'OuestRecruiting
- Institut Bergonié
- Centre François BaclesseRecruiting
- Centre Jean PerrinRecruiting
- Centre Oscar LambretRecruiting
- Hôpital Jeanne de FlandreRecruiting
- Institut Paoli CalmettesRecruiting
- ICM-Val d'AurelleRecruiting
- Hôpital Européen Georges PompidouRecruiting
- Centre Hospitalier Lyon SudRecruiting
- Clinique MathildeRecruiting
- Centre Henri BecquerelRecruiting
- Institut de Cancérologie de l'Ouest
- Hôpital de Hautepierre
- Institut de Cancérologie de LorraineRecruiting
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Arm A (PDS or IDS + HIPEC)
Arm B (PDS or IDS)
Surgery (Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS)) + Neo or Adjuvant chemotherapy (standard care) + HIPEC (hyperthermic intraperitoneal chemotherapy) Patients in this experimental arm will receive surgery (either PDS or IDS) and Neo and/or Adjuvant chemotherapy (CT) (as per standard care) combined with HIPEC. Patients undergoing PDS will also be receiving 6 cycles adjuvant CT according to the standard care (ideally 6 weeks post-surgery). Patient undergoing IDS will start with 6 cycles of neo-adjuvant CT with a 3 - 5 weeks washout period (4 - 6 weeks if administered Bevacizumab) prior to surgery. They may also undergo additional adjuvant CT post-surgery according to the standard care.
Surgery (Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS)) + Neo or Adjuvant chemotherapy ONLY (standard care, without HIPEC) Patients in the control group will ONLY receive the standard care, which consists of surgery (PDS or IDS) with Neo and/or Adjuvant chemotherapy (CT). Patients undergoing PDS will be receiving 6 cycles adjuvant CT according to the standard care (ideally 6 weeks post-surgery). Patient undergoing IDS will start with 6 cycles of neo-adjuvant CT with a 3 - 5 weeks washout period (4 - 6 weeks if administered Bevacizumab) prior to surgery. They may also undergo additional adjuvant CT post-surgery according to the standard care.