Clinical trial · Observational
Photon/Proton Radiation Therapy for Carcinoma of the Skin of the Head and Neck
A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck With Perineural Invasion
NCT00797043CI-TRIAL-00025831SK01terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow enrollment, feasibility issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Skin Head and Neck | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Photon/Proton Radiation Therapy
- description
- Data consolidation and analysis
Primary outcomes (1)
- measure
- Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth)
- timeFrame
- 1 year following the completion of radiation therapy
Secondary outcomes (1)
- measure
- Collect and analyze tumor control outcomes.
- timeFrame
- When each patient has been followed for a minimum of 6 months and then again at 24 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDBALLANTYNE 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. PMID 14070757
- BACKGROUNDCottel 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. PMID 6749931
- BACKGROUNDMendenhall 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. PMID 2753698
- BACKGROUNDMendenhall 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. PMID 3597161
- BACKGROUNDAl-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. PMID 11713722
- BACKGROUNDMendenhall 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. PMID 11774406
- BACKGROUNDParsons 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. PMID 7960976
- 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.