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

International Atomic Energy Agency

Status and phase: Unknown; Phase 3

Conditions: Cancer of the Cervix

Treatments: Radiation: Radiotherapy with cisplatin; Radiation: Radiotherapy alone

Study type: Interventional

Funder types: Other

Identifiers

NCT00122746

E33022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 322 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cancer of the cervix
• AIDS

Exclusion criteria

• Unable to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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322 participants in 2 patient groups

Radiotherapy alone

Active Comparator group

Description:

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

Treatment:

Radiation: Radiotherapy alone

Radiotherapy plus Chemotherapy

Experimental group

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

Treatment:

Radiation: Radiotherapy with cisplatin