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

Primary Purpose

Cancer of the Cervix

Status

Unknown status

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Radiotherapy alone

Radiotherapy with cisplatin

About this trial

This is an interventional treatment trial for Cancer of the Cervix focused on measuring Cervical Cancer, AIDS, External Beam Radiotherapy, Brachytherapy, Cisplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Cancer of the cervix AIDS Exclusion Criteria: Unable to give informed consent

Sites / Locations

Dept. of Atomic Energy, Tata Memorial CentreRecruiting
Johannesburg Hospital
Ocean Road Cancer InstituteRecruiting
Radiotherapy CentreRecruiting
Radiotherapy Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiotherapy alone

Radiotherapy plus Chemotherapy

Arm Description

EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A

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

Outcomes

Primary Outcome Measures

3 year recurrence free survival

Secondary Outcome Measures

Incidence of Grade 3 acute toxicity

Pelvic control rates

Tumour response at 3 months.

Cancer specific survival rates.

Overall survival rates.

Acute and late toxicities after the treatment.

Full Information

NCT ID

NCT00122746

First Posted

July 19, 2005

Last Updated

October 12, 2011

Sponsor

International Atomic Energy Agency

1. Study Identification

Unique Protocol Identification Number

NCT00122746

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

December 2004 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

International Atomic Energy Agency

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of the Cervix

Keywords

Cervical Cancer, AIDS, External Beam Radiotherapy, Brachytherapy, Cisplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

322 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy alone

Arm Type

Active Comparator

Arm Description

EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A

Arm Title

Radiotherapy plus Chemotherapy

Arm Type

Experimental

Arm Description

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 Type

Radiation

Intervention Name(s)

Radiotherapy alone

Intervention Description

EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy with cisplatin

Intervention Description

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 Measure Information:

Title

3 year recurrence free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Incidence of Grade 3 acute toxicity

Time Frame

3 months

Title

Pelvic control rates

Time Frame

3 years

Title

Tumour response at 3 months.

Time Frame

3 months

Title

Cancer specific survival rates.

Time Frame

3 years

Title

Overall survival rates.

Time Frame

3 years

Title

Acute and late toxicities after the treatment.

Time Frame

up to 3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cancer of the cervix AIDS Exclusion Criteria: Unable to give informed consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eduardo H. Zubizarreta, M.D.

Phone

+43-1-2600

Ext

22401

e.h.zubizarreta@iaea.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo H. Zubizarreta, M.D.

Organizational Affiliation

International Atomic Energy Agency

Official's Role

Study Director

Facility Information:

Facility Name

Dept. of Atomic Energy, Tata Memorial Centre

City

Mumbai

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Reena Engineer, MD

reena_engineer@rediffmail.com

First Name & Middle Initial & Last Name & Degree

Reena Engineer, MD

Facility Name

Johannesburg Hospital

City

Johannesburg

Country

South Africa

Individual Site Status

Active, not recruiting

Facility Name

Ocean Road Cancer Institute

City

Dar Es Salaam

Country

Tanzania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Twalib Ngoma, MD

ngoma@uccmail.co.tz

First Name & Middle Initial & Last Name & Degree

Twalib Ngoma, MD

Facility Name

Radiotherapy Centre

City

Kampala

Country

Uganda

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joseph Kigula, MD

jbkigula@yahoo.com

First Name & Middle Initial & Last Name & Degree

Joseph Kigula, MD

Facility Name

Radiotherapy Centre

City

Harare

Country

Zimbabwe

Individual Site Status

Active, not recruiting

12. IPD Sharing Statement

Links:

URL

http://www.iaea.org

Description

International Atomic Energy Agency. Research Contracts Administration

Learn more about this trial

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

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