Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122746
Status:
UNKNOWN
Last Update Posted:
2011-10-13
First Post:
2005-07-19
Brief Title:
Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
Sponsor:
International Atomic Energy Agency
Organization:
International Atomic Energy Agency
Study Overview
Official Title:
Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2011-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgsqm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None