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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00193830
Other study ID # TMH/11062/1996/Cx_HDR STUDY
Secondary ID
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
Est. primary completion date
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


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.
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