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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00122746
Recruitment Status : Unknown
Verified October 2011 by International Atomic Energy Agency.
Recruitment status was:  Recruiting
First Posted : July 22, 2005
Last Update Posted : October 13, 2011
Sponsor:
Information provided by (Responsible Party):
International Atomic Energy Agency

Tracking Information
First Submitted Date  ICMJE July 19, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date October 13, 2011
Study Start Date  ICMJE December 2004
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2011)
3 year recurrence free survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2011)
  • Incidence of Grade 3 acute toxicity [ Time Frame: 3 months ]
  • Pelvic control rates [ Time Frame: 3 years ]
  • Tumour response at 3 months. [ Time Frame: 3 months ]
  • Cancer specific survival rates. [ Time Frame: 3 years ]
  • Overall survival rates. [ Time Frame: 3 years ]
  • Acute and late toxicities after the treatment. [ Time Frame: up to 3 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
Official Title  ICMJE Doctoral CRP on Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer of the Cervix
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Radiotherapy alone
    EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
    Intervention: Radiation: Radiotherapy alone
  • 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
    Intervention: Radiation: Radiotherapy with cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 12, 2011)
322
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cancer of the cervix
  • AIDS

Exclusion Criteria:

  • Unable to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   South Africa,   Tanzania,   Uganda,   Zimbabwe
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00122746
Other Study ID Numbers  ICMJE E33022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party International Atomic Energy Agency
Study Sponsor  ICMJE International Atomic Energy Agency
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eduardo H. Zubizarreta, M.D. International Atomic Energy Agency
PRS Account International Atomic Energy Agency
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP