Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
Primary Purpose
Peritoneal Carcinomatosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paclitaxel
Radical surgery-peritonectomy
Sponsored by
About this trial
This is an interventional treatment trial for Peritoneal Carcinomatosis focused on measuring ovarian cancer
Eligibility Criteria
Inclusion Criteria:
- age ranged between 18 and 75 years old;
- histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian cancer (stage IIIc- FIGO (International Federation of Gynecology and Obstetrics));
- Karnofsky index > 70 or performance status ≤2;
- informed consent form filled out correctly.
Exclusion Criteria:
- unfulfillment of inclusion criteria;
- extraabdominal metastasis or stage IV FIGO (liver, lung, bone, etc);
- concomitance of another malignant neoplasm;
- renal, hepatic or cardiovascular dysfunction;
- intolerance during the treatment; - (6) refusal to participate in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
normothermic (36-37ºC)
hyperthermic (41-42ºC)
Arm Description
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 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in continuous hyperthermic perfusion (41-42ºC).
Outcomes
Primary Outcome Measures
The Grouped Miller and Payne (MP) System for Pathological Response: G1 (Minimal Changes and < 30% Cells Tumour Reduction That Includes MP G1-G2), G3 (Microscopic Foci, Cells Tumour Reduction up to >90% That Includes MP G3-G4) and G5 (no Residual Tumour)
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02739698
First Posted
April 4, 2016
Last Updated
July 4, 2017
Sponsor
Maimónides Biomedical Research Institute of Córdoba
1. Study Identification
Unique Protocol Identification Number
NCT02739698
Brief Title
Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
Official Title
Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis
Keywords
ovarian cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normothermic (36-37ºC)
Arm Type
Experimental
Arm Description
Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in room temperature (36-37ºC).
Arm Title
hyperthermic (41-42ºC)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Procedure
Intervention Name(s)
Radical surgery-peritonectomy
Primary Outcome Measure Information:
Title
The Grouped Miller and Payne (MP) System for Pathological Response: G1 (Minimal Changes and < 30% Cells Tumour Reduction That Includes MP G1-G2), G3 (Microscopic Foci, Cells Tumour Reduction up to >90% That Includes MP G3-G4) and G5 (no Residual Tumour)
Description
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).
Time Frame
The biopsies were taken before and after the treatment (intraperitoneal intraoperative chemotherapy for 60 minutes) and then they were analysed by two blinded pathologists.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ranged between 18 and 75 years old;
histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian cancer (stage IIIc- FIGO (International Federation of Gynecology and Obstetrics));
Karnofsky index > 70 or performance status ≤2;
informed consent form filled out correctly.
Exclusion Criteria:
unfulfillment of inclusion criteria;
extraabdominal metastasis or stage IV FIGO (liver, lung, bone, etc);
concomitance of another malignant neoplasm;
renal, hepatic or cardiovascular dysfunction;
intolerance during the treatment; - (6) refusal to participate in the study.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24447964
Citation
Fernandez-Peralbo MA, Priego-Capote F, Luque de Castro MD, Casado-Adam A, Arjona-Sanchez A, Munoz-Casares FC. LC-MS/MS quantitative analysis of paclitaxel and its major metabolites in serum, plasma and tissue from women with ovarian cancer after intraperitoneal chemotherapy. J Pharm Biomed Anal. 2014 Mar;91:131-7. doi: 10.1016/j.jpba.2013.12.028. Epub 2014 Jan 2.
Results Reference
result
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Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
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