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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193830
• Other study ID #: TMH/11062/1996/Cx_HDR STUDY
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 5, 2015
• Start date: May 1996
• Est. completion date: January 2007

Study information

• Verified date: January 2007
• Source: Tata Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Department of Atomic Energy
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of Cervix
• Cancer of the Cervix
• Cervical Cancer
• Cervix Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• HIgh Dose Rate Vs Low DOse Rate Brachytherapy

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai	Maharastra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To asses the feasibility of high dose rate brachytherapy
Primary	To compare the early and late reactions of high dose rate brachytherapy in contrast with low dose rate brachytherapy.
Primary	To compare the over-all survival and disease free survival in the two regimens.