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Comparative Effectiveness of HIPEC Following Interval Debulking Surgery in Patients With Advanced-stage Ovarian Cancer

NCT03448354 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2019-07-05

No results posted yet for this study

Summary

Ovarian cancer is a lethal malignancy and reported as a fifth leading cause of death in all age in the developed country. Most of the ovarian cancer patients are diagnosed at advanced stages due to an inadequate screening tool and a lack of clinical symptoms. Optimal cytoreductive surgery with no gross residual disease followed platinum-based adjuvant chemotherapy has been the most effective therapeutic strategy in the treatment of advanced ovarian cancer. However, the optimal surgical procedure is not always possible, especially in patients with extensive disease or women with poor performance status. Neoadjuvant chemotherapy(NAC) followed interval debulking surgery (IDS) is an alternative therapeutic option for these patients. There is growing interest in the use of HIPEC (hyperthermic intraperitoneal chemotherapy) for ovarian cancer, and early data on HIPEC as a component of front-line therapy of advanced ovarian cancer are encouraging. However, intraperitoneal chemotherapy is not actively used in the treatment of ovarian cancer due to the catheter-related complications or inconvenience. The aim of this study is to evaluate the effectiveness and safety of HIPEC after interval debulking surgery in advanced ovarian cancer patients.

Conditions

Interventions

PROCEDURE

HIPEC

HIPEC(paclitaxel 175mg/m2, 90min; open or closed technique) after IDS . IDS is recommended within 4 weeks after the 3rd NAC cycle. HIPEC procedure is allowed only in case of residual disease less than 5mm.

Sponsors & Collaborators

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • Suk-Joon Chang, MD, PhD · Ajou University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-26
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • South Korea

Study Locations

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Entities

Diseases

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 NCT03448354 on ClinicalTrials.gov