Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients

Cancer of the Cervix Clinical Trial

Official title: Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of the Cervix
• Uterine Cervical Neoplasms

• NCT number: NCT00122746
• Study type: Interventional
• Source: International Atomic Energy Agency
• Contact: Eduardo H. Zubizarreta, M.D.
• Phone: +43-1-2600
• Email: e.h.zubizarreta@iaea.org
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2004