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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Esophageal Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Head and Neck Carcinoma; Malignant Digestive System Neoplasm; Lung Carcinoma; Genitourinary System Carcinoma; Malignant Solid Neoplasm; Breast Carcinoma; Malignant Central Nervous System Neoplasm

Treatments: Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Study type: Observational

Funder types: Other

Identifiers

NCT00991094

NCI-2020-08092 (Registry Identifier)

PCR05-0207 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 1 patient group

Observational (questionnaire)

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment