Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment

Launched by UNICANCER · Jun 17, 2011

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for women with recurrent epithelial ovarian cancer. The goal is to see if adding HIPEC to standard treatment can help patients live longer, specifically aiming to improve overall survival by about 12 months for those whose cancer has returned after initial treatment. The trial will include around 444 patients over three years, and it’s currently active but not recruiting new participants.

To be eligible for this trial, patients need to be at least 18 years old and have a specific type of ovarian cancer that has come back at least six months after their first treatment. They must also be in good overall health, meaning they can perform daily activities without major limitations. Participants will undergo surgery to remove as much of the cancer as possible, followed by HIPEC, where heated chemotherapy is delivered directly into the abdominal cavity. It's important for potential participants to discuss with their doctor to see if this trial is a good fit for them and to understand the requirements and expectations involved.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Patient age ≥ 18 years
• • Performance Status WHO \< 2
• • Initially treated for Epithelial Ovarian Carcinoma
• • Patient with only peritoneal relapse occurred at least 6 month from the initial treatment, resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal)
• • Platinum based second-line chemotherapy before surgery with either carboplatine-paclitaxel, or carboplatine-caelyx
• • Complete cytoreductive surgery
• • The surgery has to be planned 5 to 8 weeks from the last 2nd of chemotherapy
• • No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
• • No Renal insufficiency (serum creatinine \< 1,5 time the normal limit, creatinine clearance \> 80 mL/min). calculated with MDRD method
• • Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
• • No contraindication to general anaesthesia for heavy surgery
• • Patients having read, signed and dated Informed consent before any study procedure
• • Childbearing patients have to take appropriate contraceptive methods during the treatment and until 6 months after the treatment
• Exclusion Criteria:
• • Patient age \<18 years
• • Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma)
• • Hypersensitivity to Platinum compound
• • Distant metastasis
• • Use of anti-angiogenic treatment
• • Patient with other concurrent severe life threatening disease
• • The need to perform more than two segmental digestive resections during the CRS +/- HIPEC surgery
• • Any progressive disease during the IV systemic second-line chemotherapy (platine-based)
• • Incomplete cytoreductive surgery with macroscopical residual disease (Sugarbaker \> CC1)
• • Early relapse: less than 6 mois after the end of the first treatment
• • Ovarian tumor other than Epithelioma Ovarian Cancer
• • Uncontrolled infection
• • Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• • Clinically significant cardiovascular disease contraindicating the hyper hydratation, which is necessary for HIPEC
• • Patient already treated with HIPEC for the ovarian cancer
• • Individual deprived of liberty or placed under the authority of a tutor