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

All India Institute Of Medical Science (AIIMS)

Status and phase: Unknown; Phase 3

Conditions: Ovarian Carcinoma

Treatments: Other: timing of surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00715286

I473

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

A

Active Comparator group

Description:

Conventional arm: primary surgery followed by chemotherapy

Treatment:

Other: timing of surgery

Other: timing of surgery

B

Experimental group

Description:

Neoadjuvant chemotherapy followed by interval debulking

Treatment:

Other: timing of surgery

Other: timing of surgery