Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-03-31

Brief Summary

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A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues (R0) or macroscopic tumor residues \< 1cm (R1)) followed by hyperthermia against normothermia intraperitoneal intraoperative chemotherapy with paclitaxel

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Detailed Description

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Conditions

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Peritoneal Carcinomatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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normothermic (36-37ºC)

Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in room temperature (36-37ºC).

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

Radical surgery-peritonectomy

Intervention Type PROCEDURE

hyperthermic (41-42ºC)

Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in continuous hyperthermic perfusion (41-42ºC).

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

Radical surgery-peritonectomy

Intervention Type PROCEDURE

Interventions

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Paclitaxel

Intervention Type DRUG

Radical surgery-peritonectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. age ranged between 18 and 75 years old;
2. histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian cancer (stage IIIc- FIGO (International Federation of Gynecology and Obstetrics));
3. Karnofsky index \> 70 or performance status ≤2;
4. informed consent form filled out correctly.

2. extraabdominal metastasis or stage IV FIGO (liver, lung, bone, etc);
3. concomitance of another malignant neoplasm;
4. renal, hepatic or cardiovascular dysfunction;
5. intolerance during the treatment; - (6) refusal to participate in the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No