Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer - Full Text View

Sponsor:	Vanderbilt-Ingram Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00897793

Purpose

RATIONALE: Measuring levels of growth factor in the blood of patients with cancer in the laboratory may help doctors predict how patients will respond to treatment with radiation therapy.

PURPOSE: This research study is looking at growth factor in patients with epithelial cancer who are undergoing radiation therapy.

Condition	Intervention
Breast Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Prostate Cancer	Other: laboratory biomarker analysis Radiation: radiation therapy

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Pilot Study of TGF-beta as a Potential Target for Prevention of Radiation-Induced Injury

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Prostate Cancer Tonsils and Adenoids

U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:

TGF-beta levels [ Time Frame: Off treatment date ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	January 2006
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
cancer patients recommended for radiation therapy	Other: laboratory biomarker analysis blood sample taken prior to radiation treatment, after day one, and weekly after treatments Radiation: radiation therapy radiation treatments vary by patient per doctors' recommendation

Detailed Description:

OBJECTIVES:

To determine whether there is a dose-dependent increase in TGF-beta following radiotherapy in patients with epithelial cancer.

OUTLINE: Patients undergo blood samples collection prior to treatment, 24-72 hours after the first fraction of radiotherapy, and at the end of radiotherapy. Samples are analyzed to compare pre- and post-treatment TGF-beta levels.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

People who have cancer and will have radiation therapy

Criteria

DISEASE CHARACTERISTICS:

Known diagnosis of an epithelial cancer, including any of the following:
- Head and neck
- Lung
- Breast
- Colorectal
- Prostate
Radiotherapy must be a component of planned treatment therapy

PATIENT CHARACTERISTICS:

No serious medical or psychiatric illnesses which would prevent informed consent

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897793

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

A. Bapsi Chakravarthy, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	Bapsi Chak, M.D., Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00897793 History of Changes
Other Study ID Numbers:	VICC-RAD-0576, P30CA068485, VU-VICC-RAD-0576
Study First Received:	May 9, 2009
Last Updated:	April 19, 2011
Health Authority:	United States: Vanderbilt University Human Research Protection Program

Keywords provided by Vanderbilt-Ingram Cancer Center:

recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage I squamous cell carcinoma of the larynx
stage I verrucous carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx

recurrent adenoid cystic carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent verrucous carcinoma of the oral cavity
stage I adenoid cystic carcinoma of the oral cavity
stage I mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity

Additional relevant MeSH terms:

Breast Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases

Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012