Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer (EOC): A Phase III Randomized Study

July 14, 2008 updated by: All India Institute of Medical Sciences, New Delhi

Neoadjuvant Chemotherapy (NACT) Followed by Interval Debulking Surgery vs Upfront Surgery Followed by Chemotherapy (CT) in Advanced Epithelial Ovarian Carcinoma (EOC): A Prospective Randomized Study

To determine the impact of Neoadjuvant chemotherapy on surgical debulking rate, overall and disease-free survival and quality of life (QOL) in patients with advanced EOC.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Recruiting
        • All India Institute of medical Sciences
        • Contact:
        • Principal Investigator:
          • Lalit Kumar, DM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age:20 to 65 years
  • Epithelial ovarian carcinoma
  • Stage IIIc & IV (pleural effusion only)
  • ECOG PS 0-2
  • Cytology/biopsy positive patients
  • Good compliance
  • Previously untreated patients

Exclusion Criteria:

  • Any medical contraindication of surgery
  • Psychiatric illness
  • Cardiac, liver or renal dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Conventional arm: primary surgery followed by chemotherapy
Other: timing of surgery
Surgery is followed by chemotherapy
Other: timing of surgery
Chemotherapy is followed by surgery
Experimental: B
Neoadjuvant chemotherapy followed by interval debulking
Other: timing of surgery
Surgery is followed by chemotherapy
Other: timing of surgery
Chemotherapy is followed by surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group
Time Frame: post surgery
post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
post operative morbidity
Time Frame: 3 weeks post op
3 weeks post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Principal Investigator: Lalit Kumar, DM, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Anticipated)

April 1, 2007

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

July 15, 2008

Last Update Submitted That Met QC Criteria

July 14, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I473

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe