Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT00991094
Brief 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.
Study:
NCT00991094
Study Brief:
Protocol Section:
NCT00991094