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

Breast Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00991094
Study type Observational
Source M.D. Anderson Cancer Center
Contact Steven J. Frank
Phone 713-563-2300
Email sjfrank@mdanderson.org
Status Recruiting
Phase
Start date May 27, 2005
Completion date December 31, 2025
View Details
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