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

Peritoneal Carcinomatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02739698
• Other study ID #: PI 0678-10
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 4, 2016
• Last updated: April 11, 2016
• Start date: July 2012

Study information

• Verified date: April 2016
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Exclusion Criteria:

1. unfulfillment of inclusion criteria;

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Carcinoma
• Ovarian Neoplasms
• Peritoneal Carcinomatosis

Intervention

Drug:
• Paclitaxel

Procedure:
• Radical surgery-peritonectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological response change (Miller & Payne System )	Histopathology scoring system to assess response, previous and post intraperitoneal intraoperative chemotherapy. Compare cancer cellularity of the biopsy (before treatment) with the other biopsy (after treatment).	60 minutes