Trial | NCT00122746  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    cisplatin ...

  • Study Participants

    322
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 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 Started
Dec 31
2004
Primary Completion
Jun 30
2012
Anticipated
Last Update
Oct 13
2011
Estimate

Radiation Radiotherapy alone

EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A

Radiation Radiotherapy with cisplatin

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

Radiotherapy alone Active Comparator

EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A

Radiotherapy plus Chemotherapy Experimental

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

Criteria 

Inclusion Criteria:

Cancer of the cervix
AIDS

Exclusion Criteria:

Unable to give informed consent
No Results Posted