Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer (EOC): A Phase III Randomized Study
Conditions
Ovarian Carcinoma
Conditions: official terms
Neoplasms, Glandular and Epithelial - Ovarian Neoplasms
Conditions: Keywords
epithelial ovarian cancer, neoadjuvant chemotherapy, randomized study
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: timing of surgery Type: Other
Name: timing of surgery Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 20 Years
Gender: Female
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
Location
All India Institute of Medical Sciences
New Delhi, Delhi, India
Status: Recruiting
Contact: Lalit Kumar, DM - lalitaiims@yahoo.com
Start Date
November 2001
Completion Date
June 2009
Sponsors
All India Institute of Medical Sciences, New Delhi
Source
All India Institute of Medical Sciences, New Delhi
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page