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

October 12, 2011 updated by: International Atomic Energy Agency

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

322

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
      • Mumbai, India
        • Recruiting
        • Dept. of Atomic Energy, Tata Memorial Centre
        • Principal Investigator:
          • Reena Engineer, MD
        • Contact:
  • South Africa
      • Johannesburg, South Africa
        • Active, not recruiting
        • Johannesburg Hospital
  • Tanzania
      • Dar Es Salaam, Tanzania
        • Recruiting
        • Ocean Road Cancer Institute
        • Contact:
        • Principal Investigator:
          • Twalib Ngoma, MD
  • Uganda
      • Kampala, Uganda
        • Recruiting
        • Radiotherapy Centre
        • Contact:
        • Principal Investigator:
          • Joseph Kigula, MD
  • Zimbabwe
      • Harare, Zimbabwe
        • Active, not recruiting
        • Radiotherapy Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Cancer of the cervix
  • AIDS

Exclusion Criteria:

  • Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3 year recurrence free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Atomic Energy Agency

Investigators

  • Study Director: Eduardo H. Zubizarreta, M.D., International Atomic Energy Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

July 19, 2005

First Submitted That Met QC Criteria

July 21, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

October 13, 2011

Last Update Submitted That Met QC Criteria

October 12, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E33022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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