Clinical trial NCT00991094: Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
Official title: Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2009-10-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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)

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute toxicities data in patients treated with proton therapy
timeFrame: Up to 90 days after end of treatment
measure: Late toxicities data in patients treated with proton therapy
timeFrame: Starting 90 days or more after the end of radiotherapy
measure: Dose-response relationships for normal tissue toxicity after proton therapy
timeFrame: Up to 3 months after therapy
Secondary outcomes:
measure: Symptom burden
timeFrame: Up to 3 months after therapy
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Steven J Frank
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 (IMPT) versus Passive Scattering Proton Therapy (PSPT) for Non-Small Cell Lung Cancer. J Thorac Oncol. 2020 Oct 22:S1556-0864(20)30839-X. doi: 10.1016/j.jtho.2020.10.013. Online ahead of print.
citation: 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.