Clinical trial · Observational
Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults
NCT00991094CI-TRIAL-00114596recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study collects information on the side effects of proton therapy and detailed information on the proton therapy treatment plan itself. This may help researchers develop methods to predict the risk of side effects for future patients and learn the long-term benefit of proton therapy.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Genitourinary System Carcinoma | Genitourinary System Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Central Nervous System Neoplasm | Malignant Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Malignant Digestive System Neoplasm | Malignant Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (questionnaire)
- description
- 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.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (3)
- measure
- Acute toxicities data in patients treated with proton therapy
- timeFrame
- Up to 90 days after end of treatment
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGjyshi 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. PMID 33198942