Screening Study of Patient Eligibility for Participation in National Cancer Institute Radiation Therapy Clinical Trials - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020280

Purpose

RATIONALE: Screening tests may help doctors determine which patients are eligible for treatment on clinical trials.

PURPOSE: Screening trial to determine whether patients are eligible to participate in National Cancer Institute radiation therapy clinical trials.

Condition	Intervention
Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Procedure: physiologic testing

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening
Official Title:	Evaluation for NCI Radiation Oncology Branch Clinical Research Protocols

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Evaluation of patients referred to the NCI Radiation Oncology Branch during screening to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	July 2000
Estimated Primary Completion Date:	July 2025 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Evaluate patient eligibility for participation in NCI Radiation Oncology Branch protocols.
Permit standard therapy for patients ineligible for active Radiation Oncology Branch protocols who present a novel or unique clinical training opportunity or who present conditions requiring immediate intervention in order to avoid compromising patient's health.

OUTLINE: Patients undergo various diagnostic procedures and clinical testing to determine protocol eligibility. The testing and procedures may include hepatitis screen; HIV serology; MRI, CT, and PET scans; pulmonary function tests; arteriogram; tumor biopsy; and laparoscopy.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven or suspected malignant disease or benign condition for which radiotherapy is a potential treatment

PATIENT CHARACTERISTICS:

Age

1 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

No concurrent therapy unless ineligible for Radiation Oncology Branch protocol and standard therapy deemed to be in the best interest of patient and suitable for training needs of Radiation Oncology Branch staff
No concurrent participation in other research protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020280

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Kevin Camphausen, MD

NCI - Radiation Oncology Branch; ROB

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000068200, NCI-00-C-0181
Study First Received:	July 11, 2001
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00020280
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified childhood solid tumor, protocol specific
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on January 14, 2009