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A Phase III Randomized Study of Phase III Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer

Phase 3
18 Years
Open (Enrolling)
Ovarian Epithelial Cancer Recurrent

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Trial Information

A Phase III Randomized Study of Phase III Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer

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.

Inclusion Criteria:

- Patient age ≥ 18 yrs,

- Performance Status OMS < 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 et ALAT ≤ 3 time the
Upper Normal Limit,

- No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine
clearance >60 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Description:

There is a follow-up period of 4 years.

Outcome Time Frame:

from randomization to death (up to 4 years)

Safety Issue:


Principal Investigator

Jean-Marc CLASSE

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre rené Gauducheau, NANTES


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

April 2011

Completion Date:

December 2018

Related Keywords:

  • Ovarian Epithelial Cancer Recurrent
  • Fever
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial