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

NCT ID: NCT00715286

Last Updated: 2008-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Ovarian Carcinoma

Keywords

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epithelial ovarian cancer neoadjuvant chemotherapy randomized study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Conventional arm: primary surgery followed by chemotherapy

Group Type ACTIVE_COMPARATOR

timing of surgery

Intervention Type OTHER

Surgery is followed by chemotherapy

B

Neoadjuvant chemotherapy followed by interval debulking

Group Type EXPERIMENTAL

timing of surgery

Intervention Type OTHER

Chemotherapy is followed by surgery

Interventions

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timing of surgery

Surgery is followed by chemotherapy

Intervention Type OTHER

timing of surgery

Chemotherapy is followed by surgery

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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All India Institute of Medical Sciences

Principal Investigators

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Lalit Kumar, DM

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

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All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Lalit Kumar, DM

Role: CONTACT

Phone: 91-11-26593405

Email: [email protected]

Facility Contacts

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Lalit Kumar, DM

Role: primary

Other Identifiers

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I473

Identifier Type: -

Identifier Source: org_study_id