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Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix

NCT00193739 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 635

Last updated 2019-09-20

No results posted yet for this study

Summary

Carcinoma cervix is a common malignancy in women in developing countries including India. The standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these patients. However NACT-Surgery approach has never been compared to the current standard of concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3 courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to IIB squamous cell carcinoma of the uterine cervix.

Conditions

  • Cancer of Cervix

Interventions

DRUG

NACT

3 cycles of neoadjuvant chemotherapy

PROCEDURE

Radical abdominal hysterectomy (class III), BPLND & lower para aortic lymph node sampling

NACT followed by surgery

DRUG

Inj.Cisplatin

Concurrent chemo radiotherapy

RADIATION

Concurrent chemo radiotherapy

Radiation therapy will be administered to the whole pelvis region followed by intracavitary brachytherapy.

Sponsors & Collaborators

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Sudeep Gupta, MD, DM · Tata Memorial Hospital, Mumbai-400012,India

  • Shyam K Shrivastava, MD · Tata Memorial Hospital, Mumbai-400012, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-04
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00193739 on ClinicalTrials.gov