Pilot Study of Biomarkers for Radiation Therapy

Benaroya Research Institute

Status: Suspended

Conditions: Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01050725

IRB09016

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Radiation therapy patients

Description:

Individuals receiving radiation therapy as definitive or neo-adjuvant therapy for selected malignancies, including head and neck, lung, esophageal, rectal cervical and prostate cancers.