- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00715286
Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer (EOC): A Phase III Randomized Study
July 14, 2008 updated by: All India Institute of Medical Sciences, New Delhi
Neoadjuvant Chemotherapy (NACT) Followed by Interval Debulking Surgery vs Upfront Surgery Followed by Chemotherapy (CT) in Advanced Epithelial Ovarian Carcinoma (EOC): A Prospective Randomized Study
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lalit Kumar, DM
- Phone Number: 91-11-26593405
- Email: lalitaiims@yahoo.com
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110029
- Recruiting
- All India Institute of Medical Sciences
-
Contact:
- Lalit Kumar, DM
- Email: lalitaiims@yahoo.com
-
Principal Investigator:
- Lalit Kumar, DM
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Conventional arm: primary surgery followed by chemotherapy
|
Surgery is followed by chemotherapy
Chemotherapy is followed by surgery
|
Experimental: B
Neoadjuvant chemotherapy followed by interval debulking
|
Surgery is followed by chemotherapy
Chemotherapy is followed by surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group
Time Frame: post surgery
|
post surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
post operative morbidity
Time Frame: 3 weeks post op
|
3 weeks post op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lalit Kumar, DM, All India Institute of Medical Sciences, New Delhi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Primary Completion (Anticipated)
April 1, 2007
Study Completion (Anticipated)
June 1, 2009
Study Registration Dates
First Submitted
July 14, 2008
First Submitted That Met QC Criteria
July 14, 2008
First Posted (Estimate)
July 15, 2008
Study Record Updates
Last Update Posted (Estimate)
July 15, 2008
Last Update Submitted That Met QC Criteria
July 14, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Carcinoma
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- I473
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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