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Trial Title:
Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
NCT ID:
NCT00122746
Condition:
Cancer of the Cervix
Conditions: Official terms:
Uterine Cervical Neoplasms
Cisplatin
Conditions: Keywords:
Cervical Cancer
AIDS
External Beam Radiotherapy
Brachytherapy
Cisplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy alone
Description:
EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
Arm group label:
Radiotherapy alone
Intervention type:
Radiation
Intervention name:
Radiotherapy with cisplatin
Description:
EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A + weekly
cisplatin 30 mg/m2 during EBRT
Arm group label:
Radiotherapy plus Chemotherapy
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.
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:
Criteria:
Inclusion Criteria:
- Cancer of the cervix
- AIDS
Exclusion Criteria:
- Unable to give informed consent
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dept. of Atomic Energy, Tata Memorial Centre
Address:
City:
Mumbai
Country:
India
Status:
Recruiting
Contact:
Last name:
Reena Engineer, MD
Email:
reena_engineer@rediffmail.com
Investigator:
Last name:
Reena Engineer, MD
Email:
Principal Investigator
Facility:
Name:
Johannesburg Hospital
Address:
City:
Johannesburg
Country:
South Africa
Status:
Active, not recruiting
Facility:
Name:
Ocean Road Cancer Institute
Address:
City:
Dar Es Salaam
Country:
Tanzania
Status:
Recruiting
Contact:
Last name:
Twalib Ngoma, MD
Email:
ngoma@uccmail.co.tz
Investigator:
Last name:
Twalib Ngoma, MD
Email:
Principal Investigator
Facility:
Name:
Radiotherapy Centre
Address:
City:
Kampala
Country:
Uganda
Status:
Recruiting
Contact:
Last name:
Joseph Kigula, MD
Email:
jbkigula@yahoo.com
Investigator:
Last name:
Joseph Kigula, MD
Email:
Principal Investigator
Facility:
Name:
Radiotherapy Centre
Address:
City:
Harare
Country:
Zimbabwe
Status:
Active, not recruiting
Start date:
December 2004
Lead sponsor:
Agency:
International Atomic Energy Agency
Agency class:
Other
Source:
International Atomic Energy Agency
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00122746
http://www.iaea.org
