Data Collection of Normal Tissue Toxicity for Proton Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00991094
First received: October 6, 2009
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition
Cancer

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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: May 2005
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991094

Contacts
Contact: James D. Cox, MD 713-563-2300

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: James D. Cox, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: James D. Cox, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00991094     History of Changes
Other Study ID Numbers: PCR05-0207
Study First Received: October 6, 2009
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014