Nasopharynx CancerNP01NCT00797290
Photon/Proton Radiation Therapy for Carcinoma of the Nasopharynx
An observational study of Nasopharynx Cancer, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to collect outcomes information to see what effects photon/proton beam radiation has on nasopharynx cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharynx Cancer
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 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 radiaton oncology clinic
Who may be able to join
- Nasopharynx cancer.
Who cannot join
- Evidence of distant metastasis.
- Previous radiation 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 Nasopharynx
The purpose of this study is to collect outcomes information to see what effects photon/proton beam radiation has on nasopharynx cancer.
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
- Nasopharynx Cancer
- Keywords
- Nasopharynx Cancer, Proton Radiation, Outcomes
- Medical subject headings
- Nasopharyngeal Neoplasms
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 | Photon/Proton Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect and analyze morbidity outcomes
Measured: After radiation therapy, every 4 months for at least 10 years
Secondary outcomes (1)
Collect and analyze tumor control outcomes
Measured: 12 months and 24 months after radiation therapy then annually for 10 years
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 startJun 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 (16)Papers the sponsor has linked to this study.
- Other trials for Nasopharynx CancerStudies 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
- 9 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
- NCT00797290
- Sponsor's protocol ID
- UFPTI 0605-NP01
- Acronym
- NP01
- Status last verified
- Feb 2017
- First submitted
- 24 Nov 2008
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanguineti G, Geara FB, Garden AS, Tucker SL, Ang KK, Morrison WH, Peters LJ. Carcinoma of the nasopharynx treated by radiotherapy alone: determinants of local and regional control. Int J Radiat Oncol Biol Phys. 1997 Mar 15;37(5):985-96. doi: 10.1016/s0360-3016(97)00104-1.
PubMed 9169804Bailet JW, Mark RJ, Abemayor E, Lee SP, Tran LM, Juillard G, Ward PH. Nasopharyngeal carcinoma: treatment results with primary radiation therapy. Laryngoscope. 1992 Sep;102(9):965-72. doi: 10.1288/00005537-199209000-00002.
PubMed 1518360Fandi A, Altun M, Azli N, Armand JP, Cvitkovic E. Nasopharyngeal cancer: epidemiology, staging, and treatment. Semin Oncol. 1994 Jun;21(3):382-97. No abstract available.
PubMed 8209270Teo PM, Chan AT, Lee WY, Leung TW, Johnson PJ. Enhancement of local control in locally advanced node-positive nasopharyngeal carcinoma by adjunctive chemotherapy. Int J Radiat Oncol Biol Phys. 1999 Jan 15;43(2):261-71. doi: 10.1016/s0360-3016(98)00383-6.
PubMed 10030248Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, Forastiere AA, Adams G, Sakr WA, Schuller DE, Ensley JF. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099. J Clin Oncol. 1998 Apr;16(4):1310-7. doi: 10.1200/JCO.1998.16.4.1310.
PubMed 9552031Cooper JS, Lee H, Torrey M, Hochster H. Improved outcome secondary to concurrent chemoradiotherapy for advanced carcinoma of the nasopharynx: preliminary corroboration of the intergroup experience. Int J Radiat Oncol Biol Phys. 2000 Jul 1;47(4):861-6. doi: 10.1016/s0360-3016(00)00558-7.
PubMed 10863053Mendenhall WM, Riggs CE Jr, Cassisi NJ: Treatment of head and neck cancers. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds.: Cancer: Principles and Practice of Oncology. 7th ed. Philadelphia, Pa: Lippincott Williams & Wilkins, 2005., pp 662-732.
Laramore GE, ed.: Radiation Therapy of Head and Neck Cancer. Berlin: Springer-Verlag, 1989.
Cummings CW, Fredrickson JM, Harker LA, et al.: Otolaryngology - Head and Neck Surgery. Saint Louis, Mo: Mosby-Year Book, Inc., 1998.
Marks JE, Bedwinek JM, Lee F, Purdy JA, Perez CA. Dose-response analysis for nasopharyngeal carcinoma: an historical perspective. Cancer. 1982 Sep 15;50(6):1042-50. doi: 10.1002/1097-0142(19820915)50:63.0.co;2-y.
PubMed 7104948Vikram B, Mishra UB, Strong EW, Manolatos S. Patterns of failure in carcinoma of the nasopharynx: I. Failure at the primary site. Int J Radiat Oncol Biol Phys. 1985 Aug;11(8):1455-9. doi: 10.1016/0360-3016(85)90332-3.
PubMed 3926733Xia P, Fu KK, Wong GW, Akazawa C, Verhey LJ. Comparison of treatment plans involving intensity-modulated radiotherapy for nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2000 Sep 1;48(2):329-37. doi: 10.1016/s0360-3016(00)00585-x.
PubMed 10974445Lee N, Xia P, Quivey JM, Sultanem K, Poon I, Akazawa C, Akazawa P, Weinberg V, Fu KK. Intensity-modulated radiotherapy in the treatment of nasopharyngeal carcinoma: an update of the UCSF experience. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):12-22. doi: 10.1016/s0360-3016(02)02724-4.
PubMed 12007936Parsons 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 7960976Parsons JT, Bova FJ, Fitzgerald CR, Mendenhall WM, Million RR. Radiation retinopathy after external-beam irradiation: analysis of time-dose factors. Int J Radiat Oncol Biol Phys. 1994 Nov 15;30(4):765-73. doi: 10.1016/0360-3016(94)90347-6.
PubMed 7960977
Study at a glance
From the registry record, last updated by the sponsor on 10 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 Nasopharynx
- ClinicalTrials.gov ID
- NCT00797290
- Acronym / sponsor ID
- NP01 / UFPTI 0605-NP01
- Conditions
- Nasopharynx Cancer
- Keywords
- Nasopharynx Cancer, Proton Radiation, Outcomes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment, Feasibility issues
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jun 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 outcomes information to see what effects photon/proton beam radiation has on nasopharynx cancer.
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 | – | –Photon/Proton Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at radiaton oncology clinic
Key inclusion criteria (1 listed)
- Nasopharynx cancer.
Key exclusion criteria (2 listed)
- Evidence of distant metastasis.
- Previous radiation 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
Time frame: After radiation therapy, every 4 months for at least 10 years
1 secondary outcome
Collect and analyze tumor control outcomes
Time frame: 12 months and 24 months after radiation therapy then annually for 10 years
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 10 Feb 2017.
- Background: PubMed 9169804Sanguineti G, Geara FB, Garden AS, Tucker SL, Ang KK, Morrison WH, Peters LJ. Carcinoma of the nasopharynx treated by radiotherapy alone: determinants of local and regional control. Int J Radiat Oncol Biol Phys. 1997 Mar 15;37(5):985-96. doi: 10.1016/s0360-3016(97)00104-1.
- Background: PubMed 1518360Bailet JW, Mark RJ, Abemayor E, Lee SP, Tran LM, Juillard G, Ward PH. Nasopharyngeal carcinoma: treatment results with primary radiation therapy. Laryngoscope. 1992 Sep;102(9):965-72. doi: 10.1288/00005537-199209000-00002.
- Background: PubMed 8209270Fandi A, Altun M, Azli N, Armand JP, Cvitkovic E. Nasopharyngeal cancer: epidemiology, staging, and treatment. Semin Oncol. 1994 Jun;21(3):382-97. No abstract available.
- Background: PubMed 10030248Teo PM, Chan AT, Lee WY, Leung TW, Johnson PJ. Enhancement of local control in locally advanced node-positive nasopharyngeal carcinoma by adjunctive chemotherapy. Int J Radiat Oncol Biol Phys. 1999 Jan 15;43(2):261-71. doi: 10.1016/s0360-3016(98)00383-6.
- Background: PubMed 9552031Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, Forastiere AA, Adams G, Sakr WA, Schuller DE, Ensley JF. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099. J Clin Oncol. 1998 Apr;16(4):1310-7. doi: 10.1200/JCO.1998.16.4.1310.
- Background: PubMed 10863053Cooper JS, Lee H, Torrey M, Hochster H. Improved outcome secondary to concurrent chemoradiotherapy for advanced carcinoma of the nasopharynx: preliminary corroboration of the intergroup experience. Int J Radiat Oncol Biol Phys. 2000 Jul 1;47(4):861-6. doi: 10.1016/s0360-3016(00)00558-7.
- BackgroundMendenhall WM, Riggs CE Jr, Cassisi NJ: Treatment of head and neck cancers. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds.: Cancer: Principles and Practice of Oncology. 7th ed. Philadelphia, Pa: Lippincott Williams & Wilkins, 2005., pp 662-732.
- BackgroundLaramore GE, ed.: Radiation Therapy of Head and Neck Cancer. Berlin: Springer-Verlag, 1989.
- BackgroundCummings CW, Fredrickson JM, Harker LA, et al.: Otolaryngology - Head and Neck Surgery. Saint Louis, Mo: Mosby-Year Book, Inc., 1998.
- Background: PubMed 7104948Marks JE, Bedwinek JM, Lee F, Purdy JA, Perez CA. Dose-response analysis for nasopharyngeal carcinoma: an historical perspective. Cancer. 1982 Sep 15;50(6):1042-50. doi: 10.1002/1097-0142(19820915)50:63.0.co;2-y.
- Background: PubMed 3926733Vikram B, Mishra UB, Strong EW, Manolatos S. Patterns of failure in carcinoma of the nasopharynx: I. Failure at the primary site. Int J Radiat Oncol Biol Phys. 1985 Aug;11(8):1455-9. doi: 10.1016/0360-3016(85)90332-3.
- Background: PubMed 10974445Xia P, Fu KK, Wong GW, Akazawa C, Verhey LJ. Comparison of treatment plans involving intensity-modulated radiotherapy for nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2000 Sep 1;48(2):329-37. doi: 10.1016/s0360-3016(00)00585-x.
- Individual participant dataSharing planned: No
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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 Nasopharynx Cancer, 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 1 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 10 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 (time frame: After radiation therapy, every 4 months for at least 10 years). 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 NCT00797290, which also lists 16 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 10 Feb 2017.