Photon/Proton Radiation Therapy for Carcinoma of the Skin of the Head and Neck

NCT ID: NCT00797043

Last Updated: 2017-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to collect information from the questionnaire and your medical records to see what effects the proton radiation has on you and your cancer and collect and analyze morbidity outcomes: Incidence of xerostomia (dry mouth) and tumor control.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Neoplasm of Skin Head and Neck

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Photon/Proton Radiation Therapy

Data consolidation and analysis

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Carcinoma of the skin of the head and neck region with incidental or symptomatic perineural invasion.
* Biopsy-proven squamous cell carcinoma.
* Will receive treatment with proton radiation.

Exclusion Criteria

* Evidence of distant metastasis.
* Previous irradiation for head and neck cancer.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roi Dagan, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Florida Proton Therapy Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

BALLANTYNE AJ, MCCARTEN AB, IBANEZ ML. THE EXTENSION OF CANCER OF THE HEAD AND NECK THROUGH PERIPHERAL NERVES. Am J Surg. 1963 Oct;106:651-67. doi: 10.1016/0002-9610(63)90074-6. No abstract available.

Reference Type BACKGROUND
PMID: 14070757 (View on PubMed)

Cottel WI. Perineural invasion by squamous-cell carcinoma. J Dermatol Surg Oncol. 1982 Jul;8(7):589-600. doi: 10.1111/j.1524-4725.1982.tb00317.x.

Reference Type BACKGROUND
PMID: 6749931 (View on PubMed)

Mendenhall WM, Parsons JT, Mendenhall NP, Brant TA, Stringer SP, Cassisi NJ, Million RR. Carcinoma of the skin of the head and neck with perineural invasion. Head Neck. 1989 Jul-Aug;11(4):301-8. doi: 10.1002/hed.2880110404.

Reference Type BACKGROUND
PMID: 2753698 (View on PubMed)

Mendenhall WM, Parsons JT, Mendenhall NP, Million RR. T2-T4 carcinoma of the skin of the head and neck treated with radical irradiation. Int J Radiat Oncol Biol Phys. 1987 Jul;13(7):975-81. doi: 10.1016/0360-3016(87)90034-4.

Reference Type BACKGROUND
PMID: 3597161 (View on PubMed)

Al-Othman MO, Mendenhall WM, Amdur RJ. Radiotherapy alone for clinical T4 skin carcinoma of the head and neck with surgery reserved for salvage. Am J Otolaryngol. 2001 Nov-Dec;22(6):387-90. doi: 10.1053/ajot.2001.28083.

Reference Type BACKGROUND
PMID: 11713722 (View on PubMed)

Mendenhall WM, Amdur RJ, Williams LS, Mancuso AA, Stringer SP, Price Mendenhall N. Carcinoma of the skin of the head and neck with perineural invasion. Head Neck. 2002 Jan;24(1):78-83. doi: 10.1002/hed.10025.

Reference Type BACKGROUND
PMID: 11774406 (View on PubMed)

Parsons JT, Bova FJ, Fitzgerald CR, Mendenhall WM, Million RR. Radiation optic neuropathy after megavoltage external-beam irradiation: analysis of time-dose factors. Int J Radiat Oncol Biol Phys. 1994 Nov 15;30(4):755-63. doi: 10.1016/0360-3016(94)90346-8.

Reference Type BACKGROUND
PMID: 7960976 (View on PubMed)

Bhandare N, Monroe AT, Morris CG, Bhatti MT, Mendenhall WM. Does altered fractionation influence the risk of radiation-induced optic neuropathy? Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):1070-7. doi: 10.1016/j.ijrobp.2004.12.009.

Reference Type BACKGROUND
PMID: 15990010 (View on PubMed)

Mendenhall WM, Amdur RJ, Siemann DW, Parsons JT. Altered fractionation in definitive irradiation of squamous cell carcinoma of the head and neck. Curr Opin Oncol. 2000 May;12(3):207-14. doi: 10.1097/00001622-200005000-00005.

Reference Type BACKGROUND
PMID: 10841192 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UFPTI 0606-SK01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Daily vs. Non-Daily SBRT for NSCLC
NCT03624907 TERMINATED NA
DENTOFACIAL-PBT Stage 2 - Feasibility Study
NCT07057284 ENROLLING_BY_INVITATION