Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
18 Years
N/A
Female
Cancer of the Cervix
Trial Information
Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
Clinical study addresses the question of whether radiotherapy plus weekly cisplatin offers
an advantage over the same radiotherapy given alone in AIDS patients with cervix cancer.
External beam radiotherapy is used with 50 Gy in 25 daily fractions (last interim analysis,
October 2005) suggested lowering the total dose down to 46 Gy in 23 daily fractions).
Brachytherapy component was specified as either 30 Gy of LDR in a single fraction or 3
fractions of 8 Gy using HDR. Cisplatin was administered weekly at a dose of 30 mg/sqm.
Inclusion Criteria:
- Cancer of the cervix
- AIDS
Exclusion Criteria:
- Unable to give informed consent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
3 year recurrence free survival
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Eduardo H. Zubizarreta, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
International Atomic Energy Agency
Authority:
United Nations: International Atomic Energy Agency
Study ID:
E33022
NCT ID:
NCT00122746
Start Date:
December 2004
Completion Date:
Related Keywords:
- Cancer of the Cervix
- Cervical Cancer
- AIDS
- External Beam Radiotherapy
- Brachytherapy
- Cisplatin
- Uterine Cervical Neoplasms
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