Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193830
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2005-09-13
Brief Title:
High Dose Rate HDR Versus Low Dose Rate LDR Brachytherapy in Carcinoma Cervix
Sponsor:
Tata Memorial Hospital
Organization:
Tata Memorial Hospital
Study Overview
Official Title:
High Dose Rate HDR Versus Low Dose Rate LDR Brachytherapy in Carcinoma Cervix
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 feasibility early and late complications of high dose rate brachytherapy in contrast with low dose rate brachytherapy
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None