Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy

NCT00991094 | Recruiting

• 2 other identifiers: PCR05-0207NCI-2020-08092
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Carcinoma; Esophageal Carcinoma; Lung Carcinoma; Genitourinary System Carcinoma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Central Nervous System Neoplasm; Malignant Digestive System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

• Acute toxicities data in patients treated with proton therapy

  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.

  Up to 90 days after end of treatment

• Late toxicities data in patients treated with proton therapy

  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).

  Starting 90 days or more after the end of radiotherapy

• Dose-response relationships for normal tissue toxicity after proton 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.

  Up to 3 months after therapy

Secondary Outcomes (1)

• Symptom burden

  Up to 3 months after therapy

Study Arms (1)

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.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Quality-of-Life Assessment OTHER

Complete questionnaires

Also known as: Quality of Life Assessment

Observational (questionnaire)

Questionnaire Administration OTHER

Complete questionnaires

Observational (questionnaire)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for radiation treatment with protons at University of Texas M. D. Anderson Cancer Center (UTMDACC)

You may qualify if:

• 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 may not qualify if:

• Patients who are unable or unwilling to attend the required periodic follow-ups either at M.D. Anderson or at a different site

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33198942 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms; Esophageal Neoplasms; Hematologic Neoplasms; Lung Neoplasms; Central Nervous System Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Nervous System Neoplasms; Nervous System Diseases

Study Officials

• Steven J Frank

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven J. Frank

CONTACT

713-563-2300; sjfrank@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 7, 2009
• Study Start: May 27, 2005
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

US (1)