Recruiting

Proton Therapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT00991094

Conditions

Breast Carcinoma

Esophageal Carcinoma

Genitourinary System Carcinoma

Head and Neck Carcinoma

Hematopoietic and Lymphoid Cell Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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

Genitourinary System Carcinoma

Head and Neck Carcinoma

Hematopoietic and Lymphoid Cell Neoplasm

Study ID

NCT00991094

Start date

May 27, 2005

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Quality-of-Life Assessment

Complete questionnaires

Questionnaire Administration

Complete questionnaires

Primary outcome measure

  • Acute toxicities data in patients treated with proton therapy [ Time Frame: Up to 90 days after end of treatment ]
  • Late toxicities data in patients treated with proton therapy [ Time Frame: Starting 90 days or more after the end of radiotherapy ]
  • Dose-response relationships for normal tissue toxicity after proton therapy [ Time Frame: Up to 3 months after therapy ]

Central Contacts and Locations

Central contacts

Steven J. Frank

713-563-2300sjfrank@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Steven J. Frank

713-563-2300

Principal Investigator:

Steven J. Frank

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-12.