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Data Collection of Normal Tissue Toxicity for Proton Therapy

This study is currently recruiting participants.
Verified April 2017 by M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
First Posted: October 7, 2009
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
The goal of this research study is to collect information on the side effects of proton therapy and detailed information on the proton therapy treatment plan itself so that researchers can develop methods to predict the risk of side effects for future patients.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Acute and Late Toxicities Data (including second malignant neoplasms) [ Time Frame: 5 Years ]

Estimated Enrollment: 5000
Actual Study Start Date: May 2005
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Data Collection
Collection of normal-tissue toxicity data and symptom data during and after clinical proton treatment at University of Texas MDACC and of the corresponding proton dose distribution data.

Detailed Description:

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.

You will fill out quality-of-life questionnaires that should take about 15-20 minutes to complete.

This is an investigational study. Researchers expect to have about 5,000 patients on the study. All the patients will be enrolled at MD Anderson.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients, over 18 years of age, scheduled for radiation treatment with protons at Univesity of Texas MDACC.

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. A research nurse/data coordinator will consent the patient at the earliest clinical appointment if currently receiving treatment or when treatment begins. The research nurse/data coordinator has undergone adequate training in the protection of human subjects.

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991094

Contact: Steven J. Frank, MD 713-563-2300

United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Steven J. Frank, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00991094     History of Changes
Other Study ID Numbers: PCR05-0207
First Submitted: October 6, 2009
First Posted: October 7, 2009
Last Update Posted: April 5, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Proton Therapy
Proton Therapy Treatment Plan
Proton Dose Distributions
Side Effects
Normal Tissue Toxicity
Dose Response Relationship