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

NCT00193830 | Completed Phase 3

• 1 other identifier: TMH/11062/1996/Cx_HDR STUDY
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of Cervix; Cervical Cancer; Cancer of the Cervix; Cervix Cancer

Keywords

Cervical Cancer; High Dose Rate (HDR) Brachytherapy; Low Dose Rate (LDR) Brachytherapy; Acute Toxicities; Late Radiation Sequelae

Outcome Measures

Primary Outcomes (3)

• 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.

Interventions

HIgh Dose Rate Vs Low DOse Rate Brachytherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400 012, India

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Barakat syndrome

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Shyamkishore J Shrivastava, MD, DNB (RT)

  Professor & Head, Radiation Oncology, Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: May 1, 1996
• Study Completion: January 1, 2007
• Last Updated: May 6, 2015

Record last verified: 2007-01

Locations

IN (1)