Phase 2 N=43 Randomized Double-blind Treatment

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

Peritoneal Carcinomatosis

Bottom Line

View on ClinicalTrials.gov: NCT02739698 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: 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) — 18.8; 25 percentage of complete pathological resp

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Paclitaxel (Drug); Radical surgery-peritonectomy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Maimónides Biomedical Research Institute of Córdoba
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	18.8; 25	—

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

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.

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Data sourced from ClinicalTrials.gov (NCT02739698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.