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Status unknownNCT00715286Updated Jul 15, 2008

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

A Phase 3 interventional study of timing of surgery and timing of surgery in Ovarian Carcinoma, sponsored by All India Institute of Medical Sciences, New Delhi. Status unknown at 1 site in India. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-07-15.

Sponsored by All India Institute of Medical Sciences, New Delhi · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Ovarian Carcinoma

Keywords

  • epithelial ovarian cancer
  • neoadjuvant chemotherapy
  • randomized study
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 180 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

All India Institute of Medical Sciences, New Delhi is the lead sponsor of 146 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Any medical contraindication of surgery
  • Psychiatric illness
  • Cardiac, liver or renal dysfunction
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Active comparator
    A

    Conventional arm: primary surgery followed by chemotherapy

    Other: timing of surgery

  • Experimental
    B

    Neoadjuvant chemotherapy followed by interval debulking

    Other: timing of surgery

Interventions

  • Othertiming of surgery

    Surgery is followed by chemotherapy

  • Othertiming of surgery

    Chemotherapy is followed by surgery

06

What researchers measure

Primary outcomes

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

    Time frame: post surgery

Secondary outcomes

  1. post operative morbidity

    Time frame: 3 weeks post op

07

Study locations

1 of 1 sites recruiting
  • All India Institute of Medical Sciences
    New Delhi, Delhi 110029, India
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00715286
Lead sponsor
All India Institute of Medical Sciences, New Delhi
First posted
Jul 15, 2008
Start date
Nov 2001
Primary completion
Apr 2007 (estimated)
Completion
Jun 2009 (estimated)
Last update
Jul 15, 2008

Study contacts

Lalit Kumar, DM
Contact
lalitaiims@yahoo.com
91-11-26593405
Lalit Kumar, DM
principal investigator · All India Institute of Medical Sciences, New Delhi

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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