NCT00715286

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 15, 2008

Status Verified

July 1, 2008

Enrollment Period

5.4 years

First QC Date

July 14, 2008

Last Update Submit

July 14, 2008

Conditions

Ovarian Carcinoma

Keywords

epithelial ovarian cancerneoadjuvant chemotherapyrandomized study

Outcome Measures

Primary Outcomes (1)

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

    post surgery

Secondary Outcomes (1)

  • post operative morbidity

    3 weeks post op

Study Arms (2)

A

ACTIVE COMPARATOR

Conventional arm: primary surgery followed by chemotherapy

Other: timing of surgery

B

EXPERIMENTAL

Neoadjuvant chemotherapy followed by interval debulking

Other: timing of surgery

Interventions

timing of surgeryOTHER

Surgery is followed by chemotherapy

A

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Lalit Kumar, DM

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lalit Kumar, DM

CONTACT

91-11-26593405lalitaiims@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 15, 2008

Study Start

November 1, 2001

Primary Completion

April 1, 2007

Study Completion

June 1, 2009

Last Updated

July 15, 2008

Record last verified: 2008-07

Locations

IN(1)