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

This study has been completed.
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00193830
First received: September 13, 2005
Last updated: January 22, 2007
Last verified: January 2007
  Purpose

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 OPD 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.


Condition Intervention Phase
Cancer of Cervix
Cervical Cancer
Cancer of the Cervix
Cervix Cancer
Procedure: HIgh Dose Rate Vs Low DOse Rate Brachytherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 750
Study Start Date: May 1996
Estimated Study Completion Date: January 2007
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, feasibilty, early and late complications of high dose rate brachytherapy in contrast with low dose rate brachytherapy.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193830

Locations
India
Tata Memorial Hospital
Mumbai, Maharastra, India, 400 012
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Shyamkishore J Shrivastava, MD, DNB (RT) Professor & Head, Radiation Oncology, Tata Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00193830     History of Changes
Other Study ID Numbers: TMH/11062/1996/Cx_HDR STUDY
Study First Received: September 13, 2005
Last Updated: January 22, 2007
Health Authority: India: Department of Atomic Energy

Keywords provided by Tata Memorial Hospital:
Cerivcal Cancer
High Dose Rate (HDR) Brachytherapy
Low Dose Rate (LDR) Brachytherapy
Acute Toxicities
Late Radiation Sequelae

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 01, 2014