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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT00991094

Collaborator

(none)

5,000

Enrollment

Location

208.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Carcinoma Esophageal Carcinoma Genitourinary System Carcinoma Head and Neck Carcinoma Hematopoietic and Lymphoid Cell Neoplasm Lung Carcinoma Malignant Central Nervous System Neoplasm Malignant Digestive System Neoplasm Malignant Solid Neoplasm	Other: Quality-of-Life Assessment Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:

To prospectively collect data on acute and late toxicities (including second malignant neoplasms) in patients treated with proton therapy.
To collect and store the corresponding radiation dose distribution and imaging data in order to correlate normal tissue response with dose distribution.

SECONDARY OBJECTIVES:

To derive and refine dose-response relationships for normal tissue toxicity after proton therapy.
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 27, 2005

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 Complete questionnaires Other Names: Quality of Life Assessment Other: Questionnaire Administration Complete questionnaires

Arm

Intervention/Treatment

Observational (questionnaire)

Other: Quality-of-Life Assessment

Complete questionnaires

Other Names:

Quality of Life Assessment

Other: Questionnaire Administration

Complete questionnaires

Outcome Measures

Primary Outcome Measures

Acute toxicities data in patients treated with proton therapy [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.
Late toxicities data in patients treated with proton therapy [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).
Dose-response relationships for normal tissue toxicity after proton therapy [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 Outcome Measures

Symptom burden [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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