Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian C... | NCT00715286

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

NCT00715286

Sponsor

All India Institute of Medical Sciences

Status

Unknown status

Last Update Posted

Jul 15, 2008Estimated

Enrollment

180Estimated

Phase

Phase 3

Conditions

Ovarian Carcinoma

Interventions

timing of surgery
timing of surgery

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2001

Primary Completion Date

Apr 2007Estimated

Completion Date

Jun 2009Estimated

First Submitted Date

Jul 14, 2008

First Submission Date that Met QC Criteria

Jul 14, 2008

First Posted Date

Jul 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2008

Last Update Posted Date

Jul 15, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Conventional arm: primary surgery followed by chemotherapy	Other: timing of surgery
B	Experimental	Neoadjuvant chemotherapy followed by interval debulking	Other: timing of surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
timing of surgery	Other	Surgery is followed by chemotherapy	A
timing of surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group		post surgery

Secondary Outcomes

Measure	Description	Time Frame
post operative morbidity		3 weeks post op

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lalit Kumar, DM	Contact	91-11-26593405		lalitaiims@yahoo.com

Overall Officials

Name	Affiliation	Role
Lalit Kumar, DM	All India Institute of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
All India Institute of Medical Sciences	Recruiting	New Delhi	National Capital Territory of Delhi	110029	India

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms
D000077216	Carcinoma, Ovarian Epithelial

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided