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

Primary Purpose

Ovarian Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
timing of surgery
timing of surgery
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Carcinoma focused on measuring epithelial ovarian cancer, neoadjuvant chemotherapy, randomized study

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • All India Institute of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Conventional arm: primary surgery followed by chemotherapy

Neoadjuvant chemotherapy followed by interval debulking

Outcomes

Primary Outcome Measures

to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group

Secondary Outcome Measures

post operative morbidity

Full Information

First Posted
July 14, 2008
Last Updated
July 14, 2008
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT00715286
Brief Title
Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer (EOC): A Phase III Randomized Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2001 (undefined)
Primary Completion Date
April 2007 (Anticipated)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Carcinoma
Keywords
epithelial ovarian cancer, neoadjuvant chemotherapy, randomized study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Conventional arm: primary surgery followed by chemotherapy
Arm Title
B
Arm Type
Experimental
Arm Description
Neoadjuvant chemotherapy followed by interval debulking
Intervention Type
Other
Intervention Name(s)
timing of surgery
Intervention Description
Surgery is followed by chemotherapy
Intervention Type
Other
Intervention Name(s)
timing of surgery
Intervention Description
Chemotherapy is followed by surgery
Primary Outcome Measure Information:
Title
to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group
Time Frame
post surgery
Secondary Outcome Measure Information:
Title
post operative morbidity
Time Frame
3 weeks post op

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lalit Kumar, DM
Phone
91-11-26593405
Email
lalitaiims@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lalit Kumar, DM
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lalit Kumar, DM
Email
lalitaiims@yahoo.com
First Name & Middle Initial & Last Name & Degree
Lalit Kumar, DM

12. IPD Sharing Statement

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

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