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

Unicancer

Status and phase: Active, not recruiting; Phase 3

Conditions: Ovarian Epithelial Cancer Recurrent

Treatments: Drug: HIPEC; Procedure: Maximal cytoreductive surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01376752

2010-023035-42 (EudraCT Number)

FEDEGYN 02 / 0410-CHIPOR

Details and patient eligibility

About

CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required.

Full description

The patient received before the surgery a second line chemotherapy, platinum-based regimen with either carboplatine-paclitaxel, or carboplatine-caelyx. At the end of the six courses IV chemotherapy, if the disease is still responding and if a complete cytoreductive surgery seems possible, the patient is included after signed informed consent and will be operated 5 to 8 weeks after the last second-line chemotherapy cycle.

So, during the surgery the patient will be randomized if the complete cytoreductive surgery is really done and will then receive:

• either treatment A = maximal cytoreductive surgery without HIPEC
• or treatment B = maximal cytoreductive surgery with HIPEC

The HIPEC will be done at the end of the surgery. At the end of cytoreductive surgery, tumor residual disease must be null or very limited (Sugarbaker completeness cytoreduction: CC0 (no residual)-CC1 (residual < 0.25cm).

Two methods will be used for the HIPEC: Open or closed abdomen, depends on the site practice. Each site will use the same method during the study for all included patients.

Enrollment: 415 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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415 participants in 2 patient groups

maximal cytoreductive surgery without HIPEC

Active Comparator group

Description:

The participant will have a regular cytoreductive surgery without the adjunction of HIPEC.

Treatment:

Procedure: Maximal cytoreductive surgery

maximal cytoreductive surgery with HIPEC

Experimental group

Description:

The participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m²

Treatment:

Procedure: Maximal cytoreductive surgery

Drug: HIPEC