Observational Study of Proton Therapy Side Effects
This study is collecting information on patients receiving proton therapy for various cancers, including breast, esophageal, genitourinary, head and neck, and blood cancers. Researchers want to understand the short-term (acute) and long-term (late) side effects of proton therapy. You would complete questionnaires about your quality of life and symptoms. The goal is to learn how proton therapy affects patients and to predict side effects for future patients. This is an observational study, meaning you would receive standard proton therapy, and researchers would collect data on your experience. The study aims to enroll 5000 participants.
- Study design
- This is an observational study with a planned enrollment of 5000 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would complete questionnaires weekly during proton treatment, then 1 to 3 times up to 90 days from the start of treatment, and annually thereafter. Questionnaires take 15-20 minutes at baseline, weekly during treatment, and every two weeks during follow-up for up to 3 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for acute toxicities up to 90 days after treatment and for late toxicities starting 90 days or more after treatment.
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Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Steven J Frank · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Acute toxicities data in patients treated with proton therapyUp to 90 days after end of treatment
Data will be collected from all organs receiving non-negligible proton dose during treatment. For each acute normal-tissue endpoint considered, analyses will be performed using the maximum toxicity score per patient within the 90-day follow-up. Upon analysis, the distribution of observed toxicity scores for each acute normal-tissue endpoint will be reported.
- Late toxicities data in patients treated with proton therapyStarting 90 days or more after the end of radiotherapy
Data will be collected from all organs receiving non-negligible proton dose during treatment. For each late normal-tissue endpoint considered, analyses will be performed using censored time-to-event data corresponding to specified levels of injury (e.g. time to a specific grade \>= 2 late toxicity). The log-rank test will be used to compare event times in subgroups of patients with different dosimetric characteristics of treatment (e.g. portion of lung receiving \> 20 Gy: \<= 40% vs \> 40%). In addition, normal-tissue complication probability models will be fitted to data corresponding to incidence of a late endpoint within a specified time frame, with analysis limited to patients having the specified follow-up (e.g. incidence of grade \>= 2 late rectal bleeding within 2 years among patients followed for 2 years post-treatment).
- Dose-response relationships for normal tissue toxicity after proton therapyUp to 3 months after therapy
Relevant dose-volume response models from the literature, such as the Lyman model, the parallel model, or the critical-element model will be fitted to the data when possible, and model parameter estimates reported. Confidence intervals for model parameter estimates will be derived using the profile-likelihood method.