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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00193830 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix
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Scientific title:
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High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix |
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Date of first enrolment:
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May 1996 |
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Target sample size:
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750 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00193830 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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India
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Contacts
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Name:
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Shyamkishore J Shrivastava, MD, DNB (RT) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor & Head, Radiation Oncology, Tata Memorial Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cancer of Cervix
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Cancer of the Cervix
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Cervical Cancer
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Cervix Cancer
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Intervention(s)
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Procedure: HIgh Dose Rate Vs Low DOse Rate Brachytherapy
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Primary Outcome(s)
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To asses the feasibility of high dose rate brachytherapy
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To compare the early and late reactions of high dose rate brachytherapy in contrast with low dose rate brachytherapy.
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To compare the over-all survival and disease free survival in the two regimens.
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Secondary ID(s)
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TMH/11062/1996/Cx_HDR STUDY
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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