Photon/Proton Radiation Therapy for Carcinoma of the Nasopharynx

Nasopharynx Cancer Clinical Trial

— NP01  

Official title:

A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Nasopharynx

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00797290
• Other study ID #: UFPTI 0605-NP01
• Status: Terminated
• Phase: N/A
• First received: November 24, 2008
• Last updated: February 9, 2017
• Start date: June 2008
• Est. completion date: July 2015

Study information

• Verified date: February 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect outcomes information to see what effects photon/proton beam radiation has on nasopharynx cancer.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Nasopharynx cancer.

Exclusion Criteria:

• Evidence of distant metastasis.

• Previous radiation for head and neck cancer.

Related Conditions & MeSH terms

• Nasopharyngeal Neoplasms
• Nasopharynx Cancer

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (16)

Al-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. — View Citation

Bailet 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. — View Citation

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. — View Citation

Cooper 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. — View Citation

Cummings CW, Fredrickson JM, Harker LA, et al.: Otolaryngology - Head and Neck Surgery. Saint Louis, Mo: Mosby-Year Book, Inc., 1998.

Fandi A, Altun M, Azli N, Armand JP, Cvitkovic E. Nasopharyngeal cancer: epidemiology, staging, and treatment. Semin Oncol. 1994 Jun;21(3):382-97. Review. — View Citation

Laramore GE, ed.: Radiation Therapy of Head and Neck Cancer. Berlin: Springer-Verlag, 1989.

Lee 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. — View Citation

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. — View Citation

Mendenhall 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.

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. — View Citation

Parsons 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. — View Citation

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. — View Citation

Teo 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. — View Citation

Vikram 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. — View Citation

Xia 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect and analyze morbidity outcomes		After radiation therapy, every 4 months for at least 10 years
Secondary	Collect and analyze tumor control outcomes		12 months and 24 months after radiation therapy then annually for 10 years

External Links

•   Contact the University of Florida Proton Therapy Institute