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

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

June 9, 2009

Start Date ^ICMJE

July 2000

Estimated Primary Completion Date

July 2025 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00020280 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Screening Study of Patient Eligibility for Participation in National Cancer Institute Radiation Therapy Clinical Trials

Official Title ^ICMJE

Evaluation for NCI Radiation Oncology Branch Clinical Research Protocols

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Screening

Condition ^ICMJE

Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific

Intervention ^ICMJE

Other: physiologic testing

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1000

Completion Date

Estimated Primary Completion Date

July 2025 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00020280

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068200, NCI-00-C-0181

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kevin Camphausen, MD

NCI - Radiation Oncology Branch; ROB

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP