Clinical and Experimental Studies to Improve Radiotherapy... | NCT00122746

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

NCT00122746

Sponsor

International Atomic Energy Agency

Status

Unknown status

Last Update Posted

Oct 13, 2011Estimated

Enrollment

322Estimated

Phase

Phase 3

Conditions

Cancer of the Cervix

Interventions

Radiotherapy alone
Radiotherapy with cisplatin

Countries

India
South Africa
Tanzania
Uganda
Zimbabwe

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Jun 2012Estimated

Completion Date

Not provided

First Submitted Date

Jul 19, 2005

First Submission Date that Met QC Criteria

Jul 21, 2005

First Posted Date

Jul 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2011

Last Update Posted Date

Oct 13, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

322Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiotherapy alone	Active Comparator	EBRT pelvis 46 Gy, 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A	Radiation: Radiotherapy alone
Radiotherapy plus Chemotherapy	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy alone	Radiation	EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A	Radiotherapy alone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3 year recurrence free survival		3 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Grade 3 acute toxicity		3 months
Pelvic control rates		3 years
Tumour response at 3 months.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cancer of the cervix
AIDS

Exclusion Criteria:

Unable to give informed consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eduardo H. Zubizarreta, M.D.	Contact	+43-1-2600	22401	e.h.zubizarreta@iaea.org

Overall Officials

Name	Affiliation	Role
Eduardo H. Zubizarreta, M.D.	International Atomic Energy Agency	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Atomic Energy, Tata Memorial Centre	Recruiting	Mumbai			India

References Module

Citations

Not provided

ID	Term
D002583	Uterine Cervical Neoplasms
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

ID	Term
D013812	Therapeutics
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds