Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group
Outcome Time Frame:
post surgery
Safety Issue:
Yes
Principal Investigator
Lalit Kumar, DM
Investigator Role:
Principal Investigator
Investigator Affiliation:
All India Institute of Medical Sciences, New Delhi
Authority:
India: Indian Council of Medical Research
Study ID:
I473
NCT ID:
NCT00715286
Start Date:
November 2001
Completion Date:
June 2009
Related Keywords:
- Ovarian Carcinoma
- epithelial ovarian cancer
- neoadjuvant chemotherapy
- randomized study
- Carcinoma
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
