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NCT Number: NCT00991094

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

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.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Central Nervous System Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Carcinoma Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genitourinary System Carcinoma Head and Neck Carcinoma Head and Neck Neoplasms Hematologic Diseases Hematologic Neoplasms Hematopoietic and Lymphoid Cell Neoplasm Hemic and Lymphatic Diseases Lung Carcinoma Lung Diseases Lung Neoplasms Malignant Central Nervous System Neoplasm Malignant Digestive System Neoplasm Malignant Solid Neoplasm Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Steven J. Frank

CONTACT

713-563-2300

Steven J. Frank

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVES:

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality-of-Life Assessment

Other

Complete questionnaires

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Acute toxicities data in patients treated with proton therapy

    Time frame: Up to 90 days after end of treatment

    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.

  2. Late toxicities data in patients treated with proton therapy

    Time frame: Starting 90 days or more after the end of radiotherapy

    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).

  3. Dose-response relationships for normal tissue toxicity after proton therapy

    Time frame: Up to 3 months after 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.

Secondary outcomes

  1. Symptom burden

    Time frame: Up to 3 months after therapy

    Will be documented and compared using the M.D. Anderson Symptom Inventory (MDASI). The initial analysis for symptom data will be primarily descriptive in nature, and will include frequencies, proportions, means, medians, standard deviations, ranges, interquartile ranges, confidence intervals for the means, and box and whisker plots. Potential differences in symptom development between patients and between treatment variables will be explored using longitudinal analysis performed with mixed models.

Study contacts

Contact information is provided by the study sponsor or research team.

Steven J. Frank

CONTACT

[email protected]

713-563-2300

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults

Important dates

Study start
2005
Primary completion
2027
Study completion
2027
First posted
Oct 7, 2009
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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