Photon/Proton Radiation Therapy for Oropharyngeal Cancers

NCT00797446 | Terminated

• 1 other identifier: UFPTI 0601-OP01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Cancers

Keywords

Oropharyngeal; cancer; proton; radiation; outcomes

Outcome Measures

Primary Outcomes (1)

• Collect and analyze morbidity outcomes: incidence of xerostomia

  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 Outcomes (1)

• Collect and analyze tumor control outcomes.

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the Radiation Oncology Clinic

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (23)

• 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.

  PMID: 12115386 BACKGROUND

• 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.

  PMID: 10829041 BACKGROUND

• 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.

  PMID: 11872288 BACKGROUND

• 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.

  PMID: 12410537 BACKGROUND

• 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.

  PMID: 14603457 BACKGROUND

• 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.

  PMID: 8656441 BACKGROUND

• 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.

  PMID: 9632446 BACKGROUND

• 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.

  PMID: 11905723 BACKGROUND

• 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.

  PMID: 14657228 BACKGROUND

• 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.

  PMID: 6490417 BACKGROUND

• 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.

  PMID: 10941166 BACKGROUND

• 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.

  PMID: 10080608 BACKGROUND

• 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.

  PMID: 9196155 BACKGROUND

• 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.

  PMID: 7713779 BACKGROUND

• 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.

  PMID: 2042685 BACKGROUND

• 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.

  PMID: 10524409 BACKGROUND

• 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.

  PMID: 3671769 BACKGROUND

• 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.

  PMID: 10717034 BACKGROUND

• 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.

  PMID: 10924966 BACKGROUND

• 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.

  PMID: 15890592 BACKGROUND

• 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.

  PMID: 11395238 BACKGROUND

• 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.

  PMID: 16062076 BACKGROUND

• 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.

  PMID: 10623691 RESULT

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Roi Dagan, MD, MS

  University of Florida Proton Therapy Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: September 1, 2007
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

US (1)