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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00991094.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Steven Jay Frank
Phone: 713-563-2300
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSteven Jay Frank
