Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00991094
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quality-of-Life Assessment — OTHER
    Complete questionnaires
  • Questionnaire Administration — OTHER
    Complete questionnaires

Study Details

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.

Key Dates

Start date
May 27, 2005
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Acute toxicities data in patients treated with proton therapy [ Time Frame: Up to 90 days after end of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Steven J. Frank
713-563-2300
Steven J. Frank (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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