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Sponsored by: |
Tata Memorial Hospital |
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Information provided by: | Tata Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00193830 |
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 |
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Cancer of Cervix Cervical Cancer Cancer of the Cervix Cervix Cancer |
Procedure: HIgh Dose Rate Vs Low DOse Rate Brachytherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix |
Estimated Enrollment: | 750 |
Study Start Date: | May 1996 |
Estimated Study Completion Date: | January 2007 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India, Maharastra | |
Tata Memorial Hospital | |
Mumbai, Maharastra, India, 400 012 |
Principal Investigator: | Shyamkishore J Shrivastava, MD, DNB (RT) | Professor & Head, Radiation Oncology, Tata Memorial Hospital |
Study ID Numbers: | TMH/11062/1996/Cx_HDR STUDY |
Study First Received: | September 13, 2005 |
Last Updated: | January 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00193830 History of Changes |
Health Authority: | India: Department of Atomic Energy |
Cerivcal Cancer High Dose Rate (HDR) Brachytherapy Low Dose Rate (LDR) Brachytherapy Acute Toxicities Late Radiation Sequelae |
Genital Diseases, Female Uterine Cervical Neoplasms Uterine Cervical Diseases Genital Neoplasms, Female |
Uterine Diseases Uterine Neoplasms Urogenital Neoplasms Carcinoma |
Genital Diseases, Female Uterine Cervical Neoplasms Uterine Cervical Diseases Neoplasms Neoplasms by Site |
Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms Urogenital Neoplasms |