High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix
|ClinicalTrials.gov Identifier: NCT00193830|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Cervix Cervical Cancer Cancer of the Cervix Cervix Cancer||Procedure: HIgh Dose Rate Vs Low DOse Rate Brachytherapy||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix|
|Study Start Date :||May 1996|
|Estimated Study Completion Date :||January 2007|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193830
|Tata Memorial Hospital|
|Mumbai, Maharastra, India, 400 012|
|Principal Investigator:||Shyamkishore J Shrivastava, MD, DNB (RT)||Professor & Head, Radiation Oncology, Tata Memorial Hospital|