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

18 Years
Open (Enrolling)

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Trial Information

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

As part of your standard of care, you will be examined by your doctor weekly during your
routine proton therapy and then 1-3 more times up to 90 days from the start of treatment and
then at least once a year after that.

Also as part of your standard of care, certain standard laboratory blood and/or urine test
and/or radiologic tests will be done to check if the tumor is under control and to look for
any side effect of the treatment.

If you agree to take part in this study, all of the information collected during your visits
as well as detailed information on the proton treatment plan will be gathered and stored in
a computer for future analysis.

This is an investigational study. Researchers expect to have about 5,000 patients on the
study over a 5-year period. All the patients will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. All patients scheduled for radiation treatment with protons at UTMDACC are eligible
for this protocol.

2. Patients must be 18 years of age or older (patients under 18 years of age will be
eligible for a similar pediatric protocol)

3. Patients must sign a study-specific consent form prior to study entry.

Exclusion Criteria:

1. Patients who are unable or unwilling to attend the required periodic follow-ups either
at M.D.Anderson or at a different site.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Acute and Late Toxicities Data (including second malignant neoplasms)

Outcome Time Frame:

5 Years

Safety Issue:


Principal Investigator

James D. Cox, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

Related Keywords:

  • Cancer
  • Proton Therapy
  • Proton Therapy Treatment Plan
  • Proton Dose Distributions
  • Side Effects
  • Symptoms
  • Normal Tissue Toxicity
  • Dose Response Relationship



UT MD Anderson Cancer Center Houston, Texas  77030