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

Phase 3

• Conditions: Cancer of the Cervix
• Interventions: Radiation: Radiotherapy alone; Radiation: Radiotherapy with cisplatin

• Registration Number: NCT00122746
• Lead Sponsor: International Atomic Energy Agency

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.

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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-07-19
• Study First Submitted QC: 2005-07-21
• Study First Posted: 2005-07-22
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-12
• Last Update Posted: 2011-10-13
• Primary Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 322

Inclusion Criteria

• Cancer of the cervix
• AIDS

Exclusion Criteria

• Unable to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy alone	Radiotherapy alone	EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
Radiotherapy plus Chemotherapy	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

Primary Outcome Measures

Name	Time	Method
3 year recurrence free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Incidence of Grade 3 acute toxicity	3 months
Pelvic control rates	3 years
Tumour response at 3 months.	3 months
Cancer specific survival rates.	3 years
Overall survival rates.	3 years
Acute and late toxicities after the treatment.	up to 3 years

Trial Locations

Locations (4)

Johannesburg Hospital; 🇿🇦 Johannesburg, South Africa

Dept. of Atomic Energy, Tata Memorial Centre; 🇮🇳 Mumbai, India

Ocean Road Cancer Institute; 🇹🇿 Dar Es Salaam, Tanzania

Radiotherapy Centre; 🇿🇼 Harare, Zimbabwe