Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
NCT ID: NCT00991094
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2005-05-27
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Observational (questionnaire)
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.
Quality-of-Life Assessment
Complete questionnaires
Questionnaire Administration
Complete questionnaires
Interventions
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Quality-of-Life Assessment
Complete questionnaires
Questionnaire Administration
Complete questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must sign a study-specific consent form prior to study entry
Exclusion Criteria
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Steven J Frank
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Steven J. Frank
Role: primary
References
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Gjyshi O, Xu T, Elhammali A, Boyce-Fappiano D, Chun SG, Gandhi S, Lee P, Chen AB, Lin SH, Chang JY, Tsao A, Gay CM, Zhu XR, Zhang X, Heymach JV, Fossella FV, Lu C, Nguyen QN, Liao Z. Toxicity and Survival After Intensity-Modulated Proton Therapy Versus Passive Scattering Proton Therapy for NSCLC. J Thorac Oncol. 2021 Feb;16(2):269-277. doi: 10.1016/j.jtho.2020.10.013. Epub 2020 Oct 22.
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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PCR05-0207
Identifier Type: -
Identifier Source: org_study_id
NCI-2020-08092
Identifier Type: REGISTRY
Identifier Source: secondary_id
PCR05-0207
Identifier Type: OTHER
Identifier Source: secondary_id
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