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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00122746
• Other study ID #: E33022
• Status: Recruiting
• Phase: Phase 3
• First received: July 19, 2005
• Last updated: October 12, 2011
• Start date: December 2004

Study information

• Verified date: October 2011
• Source: International Atomic Energy Agency
• Contact: Eduardo H. Zubizarreta, M.D.
• Phone: +43-1-2600
• Email: e.h.zubizarreta[@]iaea.org
• Is FDA regulated: No
• Health authority: United Nations: International Atomic Energy Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 322
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cancer of the cervix

• AIDS

Exclusion Criteria:

• Unable to give informed consent

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

Intervention

Radiation:
• Radiotherapy alone
EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
• 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

Locations

Country	Name	City	State
India	Dept. of Atomic Energy, Tata Memorial Centre	Mumbai
South Africa	Johannesburg Hospital	Johannesburg
Tanzania	Ocean Road Cancer Institute	Dar Es Salaam
Uganda	Radiotherapy Centre	Kampala
Zimbabwe	Radiotherapy Centre	Harare

Sponsors (1)

Lead Sponsor	Collaborator
International Atomic Energy Agency

Countries where clinical trial is conducted

India,  South Africa,  Tanzania,  Uganda,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 year recurrence free survival		3 years	No
Secondary	Incidence of Grade 3 acute toxicity		3 months	Yes
Secondary	Pelvic control rates		3 years	No
Secondary	Tumour response at 3 months.		3 months	No
Secondary	Cancer specific survival rates.		3 years	No
Secondary	Overall survival rates.		3 years	No
Secondary	Acute and late toxicities after the treatment.		up to 3 years	Yes

External Links

•   International Atomic Energy Agency. Research Contracts Administration