Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer

Study Overview
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Brief Summary
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Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.

Detailed Description
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Randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage FIGO II, III and IV) or tumor recurrence. A cytoreductive surgery will be perform in all of the patients include in the trial, and it will be assign at randomization: HIPEC-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles. No HIPEC-arm: Cytoreductive surgery followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.

Official Title
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Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel for the Treatment of Patients With Recurrent or Primary Advanced Ovarian Cancer : A Randomised Phase 3 Study

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Drug: HIPEC
* Procedure: No HIPEC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test) Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1)) No extra-abdominal tumor disease Absence of heart failure. Adequate renal and hepatic functions Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70% Exclusion Criteria: Patients with unresectable tumor or incomplete cytoreduction. Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count <1.500/mm3 (<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections. Extra-abdominal metastases or unresectable liver metastases Presence of other malignant tumor disease. Multisegmental complete bowel obstruction. Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk Patients who refuse treatment or consent to participate in study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIPEC<br>Primary ovarian cancer FIGO stage II, III or IV or recurrent | Drug: HIPEC<br>* Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.<br>|
| Active Comparator: No HIPEC<br>Primary ovarian cancer FIGO stage II, III or IV or recurrent | Procedure: No HIPEC<br>* Cytoreductive surgery without HIPEC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | From the date of surgery to the date of death or to the end of study (follow up every 6 months till 3 years) | every 6 months till 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | From the date of surgery to the date of recurrence or to the end of study (follow up every 6 months till 18 months) | follow up every 6 months till 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIPEC, ovarian cancer, peritoneal carcinomatosis