Data Collection of Normal Tissue Toxicity for Proton Therapy
The goal of this research study is to collect information on the side effects of proton therapy and detailed information on the proton therapy treatment plan itself so that researchers can develop methods to predict the risk of side effects for future patients.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults|
- Acute and Late Toxicities Data (including second malignant neoplasms) [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Collection of normal-tissue toxicity data and symptom data during and after clinical proton treatment at University of Texas MDACC and of the corresponding proton dose distribution data.
As part of your standard of care, you will be examined by your doctor weekly during your routine proton therapy and then 1-3 more times up to 90 days from the start of treatment and then at least once a year after that.
Also as part of your standard of care, certain standard laboratory blood and/or urine test and/or radiologic tests will be done to check if the tumor is under control and to look for any side effect of the treatment.
If you agree to take part in this study, all of the information collected during your visits as well as detailed information on the proton treatment plan will be gathered and stored in a computer for future analysis.
This is an investigational study. Researchers expect to have about 5,000 patients on the study over a 5-year period. All the patients will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991094
|Contact: James D. Cox, MD||713-563-2300|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: James D. Cox, MD|
|Study Chair:||James D. Cox, MD||M.D. Anderson Cancer Center|