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
Sponsor:
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
  Purpose

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.


Condition Intervention Phase
Ovarian Carcinoma
Other: timing of surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group [ Time Frame: post surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • post operative morbidity [ Time Frame: 3 weeks post op ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: November 2001
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Conventional arm: primary surgery followed by chemotherapy
Other: timing of surgery
Surgery is followed by chemotherapy
Experimental: B
Neoadjuvant chemotherapy followed by interval debulking
Other: timing of surgery
Chemotherapy is followed by surgery

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715286

Contacts
Contact: Lalit Kumar, DM 91-11-26593405 lalitaiims@yahoo.com

Locations
India
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: Lalit Kumar, DM       lalitaiims@yahoo.com   
Principal Investigator: Lalit Kumar, DM         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Lalit Kumar, DM All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Prof Lalit Kumar, All India Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00715286     History of Changes
Other Study ID Numbers: I473
Study First Received: July 14, 2008
Last Updated: July 14, 2008
Health Authority: India: Indian Council of Medical Research

Keywords provided by All India Institute of Medical Sciences, New Delhi:
epithelial ovarian cancer
neoadjuvant chemotherapy
randomized study

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 29, 2014