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

Phase 3

• Conditions: Ovarian Carcinoma
• Interventions: Other: timing of surgery

• Registration Number: NCT00715286
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2007-04
• Status Verified: 2008-07
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Last Update Submitted: 2008-07-14
• Study First Posted: 2008-07-15
• Last Update Posted: 2008-07-15
• Study Completion: 2009-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	timing of surgery	Conventional arm: primary surgery followed by chemotherapy
B	timing of surgery	Neoadjuvant chemotherapy followed by interval debulking

Primary Outcome Measures

Name	Time	Method
to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group	post surgery

Secondary Outcome Measures

Name	Time	Method
post operative morbidity	3 weeks post op

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India