Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer (EOC): A Phase III Randomized Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
All India Institute of Medical Sciences, New Delhi
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00715286
First received: July 14, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 14, 2008 | ||||
| Last Updated Date | July 14, 2008 | ||||
| Start Date ICMJE | November 2001 | ||||
| Estimated Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group [ Time Frame: post surgery ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
post operative morbidity [ Time Frame: 3 weeks post op ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer (EOC): A Phase III Randomized Study | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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 | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Ovarian Carcinoma | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 180 | ||||
| Estimated Completion Date | June 2009 | ||||
| Estimated Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 20 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | India | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00715286 | ||||
| Other Study ID Numbers ICMJE | I473 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Prof Lalit Kumar, All India Institute of Medical Sciences | ||||
| Study Sponsor ICMJE | All India Institute of Medical Sciences, New Delhi | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | All India Institute of Medical Sciences, New Delhi | ||||
| Verification Date | July 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||