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Concomitant Chemoradiation in Advanced Stage Carcinoma Cervix

NCT00193791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2019-09-17

No results posted yet for this study

Summary

A study to evaluate the efficacy of concomitant chemoradiation as compared to radiotherapy alone. Concomitant chemoradiation is not a new treatment modality for carcinoma cervix. Studies have shown improvement in survivals with chemoradiation, but majority of the patients was in early stages. Since this treatment modality has not been tested adequately in advanced stages in our setting, the present study is being undertaken. The study arm of chemoradiation has the potential to improve the survivals by 10%, but is associated with additional 5% risk of toxicities, which are treatable. In the study arm, apart form the standard radiotherapy treatment, you will receive weekly chemotherapy injections (Cisplatin) during external radiation therapy. The study arm is associated with additional 5% acute hematological and gastrointestinal toxicities, which are treatable with medications, blood transfusions, modifications in the ongoing treatment etc.

Conditions

  • Cancer of Cervix

Interventions

OTHER

CT + RT

Injection Cisplatin 40mg/m2 weekly for 5 weeks during the entire course of external radiation therapy

Sponsors & Collaborators

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Shyamkishore J Shrivastava, MD,DNB(RT) · Professor & Head, Department of Radiation Oncology, Tata Memorial Hospital

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
2003-07-07
Primary Completion
2017-05-31
Completion
2017-12-31

Countries

  • India

Study Locations

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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 NCT00193791 on ClinicalTrials.gov