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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00991094
• Other study ID #: PCR05-0207
• Secondary ID: NCI-2020-08092PC
• Status: Recruiting
• Start date: May 27, 2005
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Steven J. Frank
• Phone: 713-563-2300
• Email: sjfrank[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Central Nervous System Neoplasms
• Digestive System Neoplasms
• Esophageal Carcinoma
• Esophageal Neoplasms
• Gastrointestinal Neoplasms
• 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
• Neoplasms
• Nervous System Neoplasms

Intervention

Other:
• Quality-of-Life Assessment
Complete questionnaires
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Symptom burden	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.	Up to 3 months after therapy

External Links

•   University of Texas MD Anderson Cancer Center Website