High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix
Primary Purpose
Cancer of Cervix, Cervical Cancer, Cancer of the Cervix
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
HIgh Dose Rate Vs Low DOse Rate Brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Cervix focused on measuring Cervical Cancer, High Dose Rate (HDR) Brachytherapy, Low Dose Rate (LDR) Brachytherapy, Acute Toxicities, Late Radiation Sequelae
Eligibility Criteria
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
Sites / Locations
- Tata Memorial Hospital
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00193830
Brief Title
High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix
Official Title
High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
May 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tata Memorial Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Cervix, Cervical Cancer, Cancer of the Cervix, Cervix Cancer
Keywords
Cervical Cancer, High Dose Rate (HDR) Brachytherapy, Low Dose Rate (LDR) Brachytherapy, Acute Toxicities, Late Radiation Sequelae
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
HIgh Dose Rate Vs Low DOse Rate Brachytherapy
Primary Outcome Measure Information:
Title
To asses the feasibility of high dose rate brachytherapy
Title
To compare the early and late reactions of high dose rate brachytherapy in contrast with low dose rate brachytherapy.
Title
To compare the over-all survival and disease free survival in the two regimens.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyamkishore J Shrivastava, MD, DNB (RT)
Organizational Affiliation
Professor & Head, Radiation Oncology, Tata Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharastra
ZIP/Postal Code
400 012
Country
India
12. IPD Sharing Statement
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High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix
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