Photon/Proton Radiation Therapy for Oropharyngeal Cancers (OP01)

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ClinicalTrials.gov Identifier: NCT00797446

Recruitment Status : Terminated (Slow enrollment, feasibility issues)

First Posted : November 25, 2008

Last Update Posted : February 7, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

University of Florida

Study Description

Brief Summary:

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

Condition or disease
Oropharyngeal Cancers

Detailed Description:

This is an outcomes study and is designed to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

Study Design

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Study Type :	Observational
Actual Enrollment :	10 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers
Study Start Date :	September 2007
Actual Primary Completion Date :	July 2015
Actual Study Completion Date :	July 2015

Groups and Cohorts

Group/Cohort
Photon/Proton Radiation Therapy Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Outcome Measures

Primary Outcome Measures :

Collect and analyze morbidity outcomes: incidence of xerostomia [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]

Secondary Outcome Measures :

Collect and analyze tumor control outcomes. [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients in the Radiation Oncology Clinic

Criteria

Inclusion Criteria:

Biopsy-proven squamous cell carcinoma of oropharynx (tonsillar pillars, tonsillar fossa, soft palate, base of tongue).
Stage-grouping:
- Stage I (T1N0)
- Stage II (T2N0)
- Favorable Stage III (T1N1/T2N1) and selected stage IV (T1-T2 early N2b)2 or less lymph node and 2 or less cm diameter lymph node
- Unfavorable stage III and selected stage IV (any T, N2c/N3)
Surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsies.
Will receive treatment with proton radiation.

Exclusion Criteria:

Evidence of distant metastasis.
Previous irradiation for head and neck cancer.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797446

Locations

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United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206

Sponsors and Collaborators

University of Florida

Investigators

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Principal Investigator:	Roi Dagan, MD, MS	University of Florida Proton Therapy Institute

More Information

Publications of Results:

Mendenhall WM, Stringer SP, Amdur RJ, Hinerman RW, Moore-Higgs GJ, Cassisi NJ. Is radiation therapy a preferred alternative to surgery for squamous cell carcinoma of the base of tongue? J Clin Oncol. 2000 Jan;18(1):35-42. doi: 10.1200/JCO.2000.18.1.35.

Other Publications:

Parsons JT, Mendenhall WM, Stringer SP, Amdur RJ, Hinerman RW, Villaret DB, Moore-Higgs GJ, Greene BD, Speer TW, Cassisi NJ, Million RR. Squamous cell carcinoma of the oropharynx: surgery, radiation therapy, or both. Cancer. 2002 Jun 1;94(11):2967-80. doi: 10.1002/cncr.10567.

Mendenhall WM, Amdur RJ, Stringer SP, Villaret DB, Cassisi NJ. Radiation therapy for squamous cell carcinoma of the tonsillar region: a preferred alternative to surgery? J Clin Oncol. 2000 Jun;18(11):2219-25. doi: 10.1200/JCO.2000.18.11.2219.

Ojiri H, Mendenhall WM, Stringer SP, Johnson PL, Mancuso AA. Post-RT CT results as a predictive model for the necessity of planned post-RT neck dissection in patients with cervical metastatic disease from squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):420-8. doi: 10.1016/s0360-3016(01)02603-7.

Mendenhall WM, Villaret DB, Amdur RJ, Hinerman RW, Mancuso AA. Planned neck dissection after definitive radiotherapy for squamous cell carcinoma of the head and neck. Head Neck. 2002 Nov;24(11):1012-8. doi: 10.1002/hed.10187.

Doweck I, Robbins KT, Mendenhall WM, Hinerman RW, Morris C, Amdur R. Neck level-specific nodal metastases in oropharyngeal cancer: is there a role for selective neck dissection after definitive radiation therapy? Head Neck. 2003 Nov;25(11):960-7. doi: 10.1002/hed.10315.

Lefebvre JL, Chevalier D, Luboinski B, Kirkpatrick A, Collette L, Sahmoud T. Larynx preservation in pyriform sinus cancer: preliminary results of a European Organization for Research and Treatment of Cancer phase III trial. EORTC Head and Neck Cancer Cooperative Group. J Natl Cancer Inst. 1996 Jul 3;88(13):890-9. doi: 10.1093/jnci/88.13.890.

Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. doi: 10.1056/NEJM199806183382503.

Pignon JP, Hill C. Meta-analyses of randomised clinical trials in oncology. Lancet Oncol. 2001 Aug;2(8):475-82. doi: 10.1016/S1470-2045(01)00453-3.

Denis F, Garaud P, Bardet E, Alfonsi M, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Calais G. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant radiochemotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004 Jan 1;22(1):69-76. doi: 10.1200/JCO.2004.08.021. Epub 2003 Dec 2.

Mendenhall WM, Parsons JT, Million RR, Cassisi NJ, Devine JW, Greene BD. A favorable subset of AJCC stage IV squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 1984 Oct;10(10):1841-3. doi: 10.1016/0360-3016(84)90259-1. No abstract available.

Mendenhall WM, Amdur RJ, Stringer SP, Villaret DB, Cassisi NJ. Stratification of stage IV SCC of the oropharynx. Head Neck. 2000 Sep;22(6):626-8. doi: 10.1002/1097-0347(200009)22:63.0.co;2-9. No abstract available.

Mancuso AA, Mukherji SK, Schmalfuss I, Mendenhall W, Parsons J, Pameijer F, Hermans R, Kubilis P. Preradiotherapy computed tomography as a predictor of local control in supraglottic carcinoma. J Clin Oncol. 1999 Feb;17(2):631-7. doi: 10.1200/JCO.1999.17.2.631.

Mendenhall WM, Parsons JT, Mancuso AA, Pameijer FJ, Stringer SP, Cassisi NJ. Definitive radiotherapy for T3 squamous cell carcinoma of the glottic larynx. J Clin Oncol. 1997 Jun;15(6):2394-402. doi: 10.1200/JCO.1997.15.6.2394.

Cooper JS, Fu K, Marks J, Silverman S. Late effects of radiation therapy in the head and neck region. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1141-64. doi: 10.1016/0360-3016(94)00421-G.

Korsten MA, Rosman AS, Fishbein S, Shlein RD, Goldberg HE, Biener A. Chronic xerostomia increases esophageal acid exposure and is associated with esophageal injury. Am J Med. 1991 Jun;90(6):701-6.

Eisbruch A, Ten Haken RK, Kim HM, Marsh LH, Ship JA. Dose, volume, and function relationships in parotid salivary glands following conformal and intensity-modulated irradiation of head and neck cancer. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):577-87. doi: 10.1016/s0360-3016(99)00247-3.

Mendenhall WM, Parsons JT, Cassisi NJ, Million RR. Squamous cell carcinoma of the tonsillar area treated with radical irradiation. Radiother Oncol. 1987 Sep;10(1):23-30. doi: 10.1016/s0167-8140(87)80066-x.

Peters LJ, Ang KK. The Role of Altered Fractionation in Head and Neck Cancers. Semin Radiat Oncol. 1992 Jul;2(3):180-194. doi: 10.1053/SRAO00200180. No abstract available.

Fu KK, Pajak TF, Trotti A, Jones CU, Spencer SA, Phillips TL, Garden AS, Ridge JA, Cooper JS, Ang KK. A Radiation Therapy Oncology Group (RTOG) phase III randomized study to compare hyperfractionation and two variants of accelerated fractionation to standard fractionation radiotherapy for head and neck squamous cell carcinomas: first report of RTOG 9003. Int J Radiat Oncol Biol Phys. 2000 Aug 1;48(1):7-16. doi: 10.1016/s0360-3016(00)00663-5.

Slater JD, Yonemoto LT, Mantik DW, Bush DA, Preston W, Grove RI, Miller DW, Slater JM. Proton radiation for treatment of cancer of the oropharynx: early experience at Loma Linda University Medical Center using a concomitant boost technique. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):494-500. doi: 10.1016/j.ijrobp.2004.09.064.

Eisbruch A, Kim HM, Terrell JE, Marsh LH, Dawson LA, Ship JA. Xerostomia and its predictors following parotid-sparing irradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):695-704. doi: 10.1016/s0360-3016(01)01512-7.

Pacholke HD, Amdur RJ, Morris CG, Li JG, Dempsey JF, Hinerman RW, Mendenhall WM. Late xerostomia after intensity-modulated radiation therapy versus conventional radiotherapy. Am J Clin Oncol. 2005 Aug;28(4):351-8. doi: 10.1097/01.coc.0000158826.88179.75.

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Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00797446
Other Study ID Numbers:	UFPTI 0601-OP01
First Posted:	November 25, 2008 Key Record Dates
Last Update Posted:	February 7, 2017
Last Verified:	February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by University of Florida:


Oropharyngeal cancer proton radiation outcomes

Additional relevant MeSH terms:

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Oropharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site	Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases

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