MedTrace Logo

Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Ovarian Cancer

NCT01091636 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2020-02-17

No results posted yet for this study

Summary

The current standard treatment for ovarian cancer, tubal cancer, and primary peritoneal cancer is maximal cytoreductive surgery followed by chemotherapy. Recent randomized trials of Gynecologic Oncology Group (GOG) revealed the survival gain in intraperitoneal chemotherapy compared to the intravenous chemotherapy after the optimal cytoreduction in ovarian cancer (GOG#104, GOG#114, GOG#172). Experts attributed such survival gain to the earlier cycles of intraperitoneal chemotherapy when adhesion was minimal from extensive cytoreductive procedures.

Hyperthermia has an anti-cancer activity itself. Especially, hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, the combination of intraperitoneal chemotherapy with hyperthermia theoretically could lead to higher response rate and better survival outcomes.

\*HIPEC: hyperthermic intraperitoneal chemotherapy

There will be an interim analysis when 50% of patients are enrolled.

At the interim analysis, a statistical test will be performed. The nominal significance levels will be determined later. The exact nominal significance level will be determined based on the exact number of events at the time of the interim analysis. The Stopping boundaries will be calculated using an O'Brien-Fleming error spending function

Conditions

  • Epithelial Ovarian Cancer

Interventions

PROCEDURE

Hyperthermic Intraperitoneal Chemotherapy

41.5 oC injected into the perfusion cisplatin (75 mg/m2)during 90min

Sponsors & Collaborators

  • Ajou University

    collaborator OTHER

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Sang-Yoon Park, MD, Ph.D. · National Cancer Center in Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2020-01-10
Completion
2020-01-10

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01091636 on ClinicalTrials.gov