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

All India Institute of Medical Sciences180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Ovarian Carcinoma

Interventions

timing of surgeryOTHER

Surgery is followed by chemotherapy

timing of surgeryOTHER

Chemotherapy is followed by surgery

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: post surgery

Secondary Outcomes

post operative morbidity

Time frame: 3 weeks post op

Central Contacts

Lalit Kumar, DM

CONTACT

91-11-26593405 lalitaiims@yahoo.com

Data from ClinicalTrials.gov

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