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Study on Early Stage Bulky Cervical Cancers

NCT01917695 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2015-08-13

No results posted yet for this study

Summary

The aim of this study is to establish the role of neoadjuvant chemotherapy and chemo irradiation in carcinoma cervix and to compare its results with the concurrent chemo irradiation in terms of overall survival, disease free survival and quality of life.

Conditions

  • Carcinoma Cervix

Interventions

DRUG

Chemotherapy

cisplatin 75 mg/m2 Paclitaxel 175 mg/m2

RADIATION

External Beam Radiotherapy

50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5

RADIATION

Brachytherapy

Ir - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT.

PROCEDURE

Radical Hysterectomy

Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection

Sponsors & Collaborators

  • Rajkumar Kottayasamy Seenivasagam

    lead OTHER

Principal Investigators

  • Rajaraman Ramamurthy, MS MCh · centre for oncology, Government Royapettah Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

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 NCT01917695 on ClinicalTrials.gov