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NCT00715286 Clinical Trial

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

Ovarian Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00715286
Other study ID # I473
Secondary ID
Status Recruiting
Phase Phase 3
First received July 14, 2008
Last updated July 14, 2008
Start date November 2001
Est. completion date June 2009

Study information
Verified date July 2008
Source All India Institute of Medical Sciences, New Delhi
Contact Lalit Kumar, DM
Phone 91-11-26593405
Email lalitaiims@yahoo.com
Is FDA regulated No
Health authority India: Indian Council of Medical Research
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date June 2009
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• timing of surgery
Surgery is followed by chemotherapy
• timing of surgery
Chemotherapy is followed by surgery

Locations
Country Name City State
India All India Institute of Medical Sciences New Delhi Delhi

Sponsors (1)
Lead Sponsor Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group post surgery Yes
Secondary post operative morbidity 3 weeks post op Yes
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