NCT00991094

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Complete questionnaires
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2005-05-27
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2009-10-07
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States