Collecting data on side effects of proton therapy for cancer treatment
Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults
This study is trying to learn about the side effects that cancer patients experience after receiving proton therapy to help improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT00991094 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather information on the acute and late side effects experienced by patients undergoing proton therapy for various types of cancer, including breast, esophageal, and head and neck carcinomas. Researchers will collect detailed data on treatment plans and radiation dose distributions to better understand the relationship between these factors and normal tissue responses. Patients will be monitored weekly during treatment and for up to 90 days post-treatment, with quality-of-life assessments conducted through questionnaires. The goal is to refine predictions of side effects and improve future treatment protocols.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for proton therapy at M.D. Anderson Cancer Center.
Not a fit: Patients who are unable or unwilling to attend the required follow-ups may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of proton therapy's safety profile and improve patient outcomes by predicting and mitigating side effects.
How similar studies have performed: Other studies have shown promise in assessing treatment-related toxicities, but this specific approach to proton therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients who are unable or unwilling to attend the required periodic follow-ups either at M.D. Anderson or at a different site
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Steven J Frank — M.D. Anderson Cancer Center
- Study coordinator: Steven J. Frank
- Email: sjfrank@mdanderson.org
- Phone: 713-563-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.