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Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
Conditions
Cancer of the Cervix
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Cervical Cancer, AIDS, External Beam Radiotherapy, Brachytherapy, Cisplatin
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiotherapy alone
Type: Radiation
Name: Radiotherapy with cisplatin
Type: Radiation
Overall Status
Recruiting
Summary
The researchers plan:
- To undertake clinical studies of radiotherapy with or without the administration of the chemotherapeutic agent cisplatin, known to be a radiosensitizer;
- To perform pre-clinical studies of the radiosensitivity of human fibroblasts and cervical cancer cell lines in culture, with or without the addition of various HIV proteins or protease inhibitors, in order to determine the extent of any cellular radiosensitizing properties of these molecules;
- To develop strategies for sensitizing tumour cells to radiation, specifically by down-regulating specific viral proteins that are known to be factors associated with resistance to radiotherapy.
- To undertake clinical studies of radiotherapy with or without the administration of the chemotherapeutic agent cisplatin, known to be a radiosensitizer;
- To perform pre-clinical studies of the radiosensitivity of human fibroblasts and cervical cancer cell lines in culture, with or without the addition of various HIV proteins or protease inhibitors, in order to determine the extent of any cellular radiosensitizing properties of these molecules;
- To develop strategies for sensitizing tumour cells to radiation, specifically by down-regulating specific viral proteins that are known to be factors associated with resistance to radiotherapy.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:
- Cancer of the cervix
- AIDS
Exclusion Criteria:
- Unable to give informed consent
- Cancer of the cervix
- AIDS
Exclusion Criteria:
- Unable to give informed consent
Locations
Dept. of Atomic Energy, Tata Memorial Centre
Mumbai, India
Johannesburg Hospital
Status: Recruiting
Contact: Reena Engineer, MD - reena_engineer@rediffmail.com
Johannesburg, South Africa
Ocean Road Cancer Institute
Status: Active, not recruiting
Dar Es Salaam, Tanzania
Radiotherapy Centre
Status: Recruiting
Contact: Twalib Ngoma, MD - ngoma@uccmail.co.tz
Kampala, Uganda
Radiotherapy Centre
Status: Recruiting
Contact: Joseph Kigula, MD - jbkigula@yahoo.com
Harare, Zimbabwe
Status: Active, not recruiting
Start Date
December 2004
Sponsors
International Atomic Energy Agency
Source
International Atomic Energy Agency
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page