Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy

Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults

This study collects information on the side effects of proton therapy and detailed information on the proton therapy treatment plan itself. This may help researchers develop methods to predict the risk of side effects for future patients and learn the long-term benefit of proton therapy.

PRIMARY OBJECTIVES:

I. To prospectively collect data on acute and late toxicities (including second malignant neoplasms) in patients treated with proton therapy.

II. To collect and store the corresponding radiation dose distribution and imaging data in order to correlate normal tissue response with dose distribution.

SECONDARY OBJECTIVES:

I. To derive and refine dose-response relationships for normal tissue toxicity after proton therapy.

II. To document and compare symptom burden weekly during treatment and twice a month for 3 months after therapy, using the M.D. Anderson Symptom Inventory (MDASI).

OUTLINE:

Patients undergoing standard of care proton therapy are assessed for toxicities weekly during proton treatment, then from 1 to 3 times up to 90 days from the start of treatment and annually thereafter. Patients also complete questionnaires over 15-20 minutes at baseline, weekly during treatment, and every 2 weeks during follow up for up to 3 months.

Inclusion Criteria:

• All patients scheduled for radiation treatment with protons at UTMDACC are eligible for this protocol
• Patients must sign a study-specific consent form prior to study entry

Exclusion Criteria:

• Patients who are unable or unwilling to attend the required periodic follow-ups either at M.D. Anderson or at a different site