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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00715286

Enrollment

180

Registered

2008-07-15

Start date

2001-11-30

Completion date

2009-06-30

Last updated

2008-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Carcinoma

Keywords

epithelial ovarian cancer, neoadjuvant chemotherapy, 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.

Interventions

OTHERtiming of surgery

Surgery is followed by chemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
post operative morbidity	3 weeks post op

Countries

India

Contacts

Primary ContactLalit Kumar, DM

lalitaiims@yahoo.com91-11-26593405

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026