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Trial record 1 of 1 for:    NCT01627093
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Medical Data Collection of Patients With Head and Neck Cancer Treated With Proton Therapy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01627093
Recruitment Status : Active, not recruiting
First Posted : June 25, 2012
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial collects medical information from patients with head and neck cancer that have received or are scheduled to receive proton therapy. Collecting and analyzing medical information from patients may provide information on the outcomes and treatment related side effects of proton therapy for head and neck cancer and help doctors improve therapy for future patients with head and neck cancer.

Condition or disease Intervention/treatment
Head and Neck Carcinoma Other: Medical Chart Review Other: Questionnaire Administration

Detailed Description:

PRIMARY OBJECTIVE:

I. To evaluate the outcomes in patients who have received treatment for their head and neck malignancy with proton radiation therapy.

OUTLINE:

Patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. Patients also have their medical records reviewed.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies
Actual Study Start Date : January 6, 2012
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Group/Cohort Intervention/treatment
Observational (questionnaire, medical chart review)
Patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. Patients also have their medical records reviewed.
Other: Medical Chart Review
Review of medical records
Other Name: Chart Review

Other: Questionnaire Administration
Complete questionnaires




Primary Outcome Measures :
  1. Overall survival analysis of proton therapy for head and neck malignancies [ Time Frame: 7 years ]
    Chart analysis performed on all patients documented to have head and neck cancer treated with proton therapy from January 1, 2008 through December 31, 2014. Overall survival estimated using Kaplan-Meier method. Cox proportional hazards regression used to explore predictors of time-to-event outcomes. Mann-Whitney test used to compare continuous parameters between temporal cohorts.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients documented to have head and neck cancer treated with proton therapy at MD Anderson Cancer Center in Houston, Texas (MDACC) from January 1, 2008 through April 30, 2012, and patients who receive treatment from May 1, 2012 through December 31, 2018
Criteria

Inclusion Criteria:

  • Patients documented to have head and neck cancer treated with proton therapy at MDACC from January 1, 2008 through April 30, 2012 and patients who receive treatment from May 1, 2012 through December 31, 2018

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): NCT01627093


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Steven J Frank M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01627093    
Other Study ID Numbers: PA11-0803
NCI-2020-00578 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PA11-0803 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020

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