Pilot Study of Biomarkers for Radiation Therapy

Suspended

• Conditions: Cancer

• Registration Number: NCT01050725
• Lead Sponsor: Benaroya Research Institute

Brief Summary

The purpose of this study is to determine whether specific assays of DNA damage repair proteins can be used in patients undergoing radiation therapy. The ultimate goal of this research is to develop clinically useful biomarkers from blood samples that could be used to customize radiation treatment for individuals, leading to reduced side effects and improved outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-15
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-06-30
• Primary Completion: 2013-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients > 18 years of age with primary lung, esophageal or rectal cancer receiving neo-adjuvant chemoradiotherapy before planned resection
• patients with clinically localized prostate cancer receiving definitive radiation therapy with external beam treatment. brachytherapy as a boost and/or hormonal therapy are allowed.
• patients with head and neck, lung, esophageal or cervical cancer who will receive definitive radiotherapy

Exclusion Criteria

• prior history of chemotherapy given within 6 months before enrollment.
• prior radiotherapy or radionuclide treatment and/or brachytherapy within 6 months prior to enrollment.
• unwillingness to comply with tests, protocol, or informed consent.
• concurrent enrollment on any protocol that would require non-compliance with treatment procedures.
• chemotherapy required within 2 hours following first dose of XRT.
• PET scan done within 48 hours of first blood draw.
• nuclear medicine exposure within 4 days prior to first draw.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States