High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix

May 5, 2015 updated by: Tata Memorial Hospital
Radiation therapy still remains mainstay of treatment for patients with carcinoma cervix in advanced stages. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary brachytherapy treatment is the time-tested modality of brachytherapy with sound radiobiological bases. But high dose rate brachytherapy is a relatively new alternative. In low dose rate brachytherapy the staff receives some radiation while in the high dose rate brachytherapy procedure complete protection to staff can be achieved as the treatment is done with remote afterloading technique. The high dose rate brachytherapy is possible as Out Patient Department procedure. Few clinical trials have proven the feasibility and efficacy of high dose rate brachytherapy in carcinoma of cervix. However, there is no concrete evidence especially in developing countries for the change of practice to HDR brachytherapy. Hence, at Tata Memorial Hospital with an aim to assess the efficacy, feasibility, early and late complications of high dose rate brachytherapy in contrast with low dose rate brachytherapy we propose this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Carcinoma cervix is the most common malignancy in Indian women and constitutes approximately 27% of all cancers as recorded in the annual report of Hospital based cancer registry 1991. Carcinoma of cervix forms one of the leading causes for death and disability due to cancers in India.

Nearly 80% of the patients with carcinoma cervix present in advanced stages. Despite the advances in conventional modalities the five-year survival is 26% and 43% for stage IIIB and stage IIB respectively. In developing countries the socio-economic problems, illiteracy, late presentation and irregular follow-up resulting in early locoregional and distant failures further compound the problem.

Radiation therapy still remains the important modality of treatment for patients with carcinoma cervix in advanced stages. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary treatment is the time-tested modality of brachytherapy for carcinoma of cervix having sound radiobiological bases. But high dose rate brachytherapy is a relatively new method. In low dose rate brachytherapy the staff receives some radiation while in the high dose rate brachytherapy procedure complete protection to staff can be achieved as the treatment is done with remote afterloading technique. The high dose rate brachytherapy is possible as OPD procedure. Various clinical trials have proved the feasibility and efficacy of high dose rate brachytherapy for carcinoma of cervix. At Tata Memorial Hospital we advocate a study to assess the efficacy, feasibility, early and late complications of high dose rate brachytherapy in contrast with low dose rate brachytherapy.

Study Type

Interventional

Enrollment

750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharastra
      • Mumbai, Maharastra, India, 400 012
        • Tata Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically proven squamous carcinoma of cervix
  • Performance index WHO grade 0 or 1
  • Patients below 65 years of age
  • Normal ECG and CVS
  • Normal hematological parameters
  • Normal renal and liver function tests

Exclusion Criteria:

  • Concomitant disease which may adversely affect the outcome
  • Poor nutritional status
  • Medical or psychological condition precluding treatment
  • Previous treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To asses the feasibility of high dose rate brachytherapy
To compare the early and late reactions of high dose rate brachytherapy in contrast with low dose rate brachytherapy.
To compare the over-all survival and disease free survival in the two regimens.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1996

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 19, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMH/11062/1996/Cx_HDR STUDY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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