Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer (EOC): A Phase III Randomized Study
NCT ID: NCT00715286
Last Updated: 2008-07-15
Study Results
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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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2001-11-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Conventional arm: primary surgery followed by chemotherapy
timing of surgery
Surgery is followed by chemotherapy
B
Neoadjuvant chemotherapy followed by interval debulking
timing of surgery
Chemotherapy is followed by surgery
Interventions
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timing of surgery
Surgery is followed by chemotherapy
timing of surgery
Chemotherapy is followed by surgery
Eligibility Criteria
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Inclusion Criteria
* Epithelial ovarian carcinoma
* Stage IIIc \& IV (pleural effusion only)
* ECOG PS 0-2
* Cytology/biopsy positive patients
* Good compliance
* Previously untreated patients
Exclusion Criteria
* Psychiatric illness
* Cardiac, liver or renal dysfunction
20 Years
65 Years
FEMALE
No
Sponsors
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All India Institute of Medical Sciences
OTHER
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
Countries
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Central Contacts
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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