Toxicity and Survival After Intensity-Modulated Proton Therapy Versus Passive Scattering Proton Therapy for NSCLC.
Olsi Gjyshi, Ting Xu, Adnan Elhammali...
https://pubmed.ncbi.nlm.nih.gov/33198942Actively Recruiting
Age: 18Years +
All Genders
ID00991094
Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults
Led by M.D. Anderson Cancer Center ยท Updated on 2026-01-02
5000
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are gathering detailed information to understand the side effects of proton therapy and how the treatment is planned. This study aims to help predict the risk of side effects for future patients and to learn about the long-term benefits of proton therapy. The focus is on collecting data about both immediate and delayed effects on normal tissues, including the possibility of second cancers. Patients receiving standard proton therapy as part of their usual care are included. During the treatment, patients are assessed weekly for any side effects. Follow-up assessments occur one to three times within 90 days after starting treatment and then annually. Patients also fill out questionnaires about their symptoms before treatment, weekly during treatment, and every two weeks for up to three months after therapy. Participants will be involved in regular symptom assessments and toxicity monitoring through questionnaires and clinical evaluations. Researchers will review acute side effects up to 90 days after treatment ends and late side effects starting after 90 days. They will also analyze how radiation dose relates to side effects and symptom burden over time. This study may last for several years, with ongoing annual follow-ups to track long-term outcomes.
CONDITIONS
Brief Title
Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- All patients scheduled for radiation treatment with protons at UTMDACC are eligible for this protocol
- Patients must sign a study-specific consent form prior to study entry
You will not qualify if you...
- Patients who are unable or unwilling to attend the required periodic follow-ups either at M.D. Anderson or at a different site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Duration of proton therapy
Participants undergoing standard of care proton therapy are assessed weekly during treatment for acute toxicities and complete questionnaires at baseline and weekly during treatment.
Weekly visits during treatment
Surveillance
Duration - Up to 3 months after therapy
Participants are assessed 1 to 3 times up to 90 days from the start of treatment and complete questionnaires every 2 weeks during follow-up for up to 3 months to monitor symptom burden and dose-response relationships.
1 to 3 visits up to 90 days and biweekly visits for up to 3 months
Long-term Monitoring
Duration - Annual assessments after 90 days post-treatment
Participants are assessed annually to monitor late toxicities starting 90 days or more after the end of radiotherapy.
Annual visits
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
S
Steven J. Frank
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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