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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


Phase 3
20 Years
65 Years
Open (Enrolling)
Female
Ovarian Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group

Outcome Time Frame:

post surgery

Safety Issue:

Yes

Principal Investigator

Lalit Kumar, DM

Investigator Role:

Principal Investigator

Investigator Affiliation:

All India Institute of Medical Sciences, New Delhi

Authority:

India: Indian Council of Medical Research

Study ID:

I473

NCT ID:

NCT00715286

Start Date:

November 2001

Completion Date:

June 2009

Related Keywords:

  • Ovarian Carcinoma
  • epithelial ovarian cancer
  • neoadjuvant chemotherapy
  • randomized study
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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