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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by International Atomic Energy Agency.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
International Atomic Energy Agency
ClinicalTrials.gov Identifier:
NCT00122746
First received: July 19, 2005
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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.

Condition Intervention Phase
Cancer of the Cervix
Radiation: Radiotherapy alone
Radiation: Radiotherapy with cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients

Resource links provided by NLM:


Further study details as provided by International Atomic Energy Agency:

Primary Outcome Measures:
  • 3 year recurrence free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Grade 3 acute toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Pelvic control rates [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Tumour response at 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Cancer specific survival rates. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival rates. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Acute and late toxicities after the treatment. [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 322
Study Start Date: December 2004
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiotherapy alone
EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
Radiation: Radiotherapy alone
EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
Experimental: Radiotherapy plus Chemotherapy
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer of the cervix
  • AIDS

Exclusion Criteria:

  • Unable to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122746

Contacts
Contact: Eduardo H. Zubizarreta, M.D. +43-1-2600 ext 22401 e.h.zubizarreta@iaea.org

Locations
India
Dept. of Atomic Energy, Tata Memorial Centre Recruiting
Mumbai, India
Contact: Reena Engineer, MD       reena_engineer@rediffmail.com   
Principal Investigator: Reena Engineer, MD         
South Africa
Johannesburg Hospital Active, not recruiting
Johannesburg, South Africa
Tanzania
Ocean Road Cancer Institute Recruiting
Dar Es Salaam, Tanzania
Contact: Twalib Ngoma, MD       ngoma@uccmail.co.tz   
Principal Investigator: Twalib Ngoma, MD         
Uganda
Radiotherapy Centre Recruiting
Kampala, Uganda
Contact: Joseph Kigula, MD       jbkigula@yahoo.com   
Principal Investigator: Joseph Kigula, MD         
Zimbabwe
Radiotherapy Centre Active, not recruiting
Harare, Zimbabwe
Sponsors and Collaborators
International Atomic Energy Agency
Investigators
Study Director: Eduardo H. Zubizarreta, M.D. International Atomic Energy Agency
  More Information

Additional Information:
No publications provided

Responsible Party: International Atomic Energy Agency
ClinicalTrials.gov Identifier: NCT00122746     History of Changes
Other Study ID Numbers: E33022
Study First Received: July 19, 2005
Last Updated: October 12, 2011
Health Authority: United Nations: International Atomic Energy Agency

Keywords provided by International Atomic Energy Agency:
Cervical Cancer
AIDS
External Beam Radiotherapy
Brachytherapy
Cisplatin

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014