Malignant Neoplasm of Skin Head and NeckSK01NCT00797043
Photon/Proton Radiation Therapy for Carcinoma of the Skin of the Head and Neck
An observational study of Malignant Neoplasm of Skin Head and Neck, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm of Skin Head and Neck
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at radiation oncology clinic
Who may be able to join
- 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.
Who cannot join
- Evidence of distant metastasis.
- Previous irradiation for head and neck cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck With Perineural Invasion
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.
Read the detailed description
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
- Malignant Neoplasm of Skin Head and Neck
- Keywords
- Carcinoma of the skin of the head and neck, Proton radiation, Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Photon/Proton Radiation Therapy | Data consolidation and analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth)
Measured: 1 year following the completion of radiation therapy
Secondary outcomes (1)
Collect and analyze tumor control outcomes.
Measured: When each patient has been followed for a minimum of 6 months and then again at 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Slow enrollment, feasibility issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of Skin Head and NeckStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roi Dagan, MD, MS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797043
- Sponsor's protocol ID
- UFPTI 0606-SK01
- Acronym
- SK01
- Status last verified
- Feb 2017
- First submitted
- 24 Nov 2008
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 14070757Cottel 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.
PubMed 6749931Mendenhall 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.
PubMed 2753698Mendenhall 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.
PubMed 3597161Al-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.
PubMed 11713722Mendenhall 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.
PubMed 11774406Parsons 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.
PubMed 7960976Bhandare 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.
PubMed 15990010Mendenhall 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.
PubMed 10841192
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck With Perineural Invasion
- ClinicalTrials.gov ID
- NCT00797043
- Acronym / sponsor ID
- SK01 / UFPTI 0606-SK01
- Conditions
- Malignant Neoplasm of Skin Head and Neck
- Keywords
- Carcinoma of the skin of the head and neck, Proton radiation, Outcomes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment, feasibility issues
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photon/Proton Radiation Therapy | – | –Data consolidation and analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at radiation oncology clinic
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Evidence of distant metastasis.
- Previous irradiation for head and neck cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth)
Time frame: 1 year following the completion of radiation therapy
1 secondary outcome
Collect and analyze tumor control outcomes.
Time frame: When each patient has been followed for a minimum of 6 months and then again at 24 months.
Results and safety
The study was stopped early (reason given: Slow enrollment, feasibility issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Background: PubMed 14070757BALLANTYNE 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.
- Background: PubMed 6749931Cottel 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.
- Background: PubMed 2753698Mendenhall 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.
- Background: PubMed 3597161Mendenhall 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.
- Background: PubMed 11713722Al-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.
- Background: PubMed 11774406Mendenhall 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.
- Background: PubMed 7960976Parsons 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.
- Background: PubMed 15990010Bhandare 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.
- Background: PubMed 10841192Mendenhall 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roi Dagan, MD, MS principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm of Skin Head and Neck, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment, feasibility issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth) (time frame: 1 year following the completion of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00797043, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.