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

NCT ID: NCT00122746

Last Updated: 2011-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Cancer of the Cervix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiotherapy alone

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

Group Type ACTIVE_COMPARATOR

Radiotherapy alone

Intervention Type RADIATION

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

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

Group Type EXPERIMENTAL

Radiotherapy with cisplatin

Intervention Type RADIATION

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

Interventions

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Radiotherapy alone

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

Intervention Type 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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Cancer of the cervix
* AIDS

Exclusion Criteria

* Unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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International Atomic Energy Agency

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eduardo H. Zubizarreta, M.D.

Role: STUDY_DIRECTOR

International Atomic Energy Agency

Locations

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Dept. of Atomic Energy, Tata Memorial Centre

Mumbai, , India

Site Status RECRUITING

Johannesburg Hospital

Johannesburg, , South Africa

Site Status ACTIVE_NOT_RECRUITING

Ocean Road Cancer Institute

Dar es Salaam, , Tanzania

Site Status RECRUITING

Radiotherapy Centre

Kampala, , Uganda

Site Status RECRUITING

Radiotherapy Centre

Harare, , Zimbabwe

Site Status ACTIVE_NOT_RECRUITING

Countries

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India South Africa Tanzania Uganda Zimbabwe

Central Contacts

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Eduardo H. Zubizarreta, M.D.

Role: CONTACT

[email protected]
+43-1-2600 ext. 22401

Facility Contacts

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Reena Engineer, MD

Role: primary

[email protected]

Twalib Ngoma, MD

Role: primary

[email protected]

Joseph Kigula, MD

Role: primary

[email protected]

Related Links

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http://www.iaea.org

International Atomic Energy Agency. Research Contracts Administration

Other Identifiers

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E33022

Identifier Type: -

Identifier Source: org_study_id