Photon/Proton Radiation Therapy for Oropharyngeal Cancers (OP01)
3. februar 2017 opdateret af: University of Florida
A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
10
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Florida
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Jacksonville, Florida, Forenede Stater, 32206
- University of Florida Proton Therapy Institute
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients in the Radiation Oncology Clinic
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Collect and analyze morbidity outcomes: incidence of xerostomia
Tidsramme: 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
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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
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Collect and analyze tumor control outcomes.
Tidsramme: 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
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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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2007
Primær færdiggørelse (Faktiske)
1. juli 2015
Studieafslutning (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først indsendt
24. november 2008
Først indsendt, der opfyldte QC-kriterier
24. november 2008
Først opslået (Skøn)
25. november 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. februar 2017
Sidst verificeret
1. februar 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UFPTI 0601-OP01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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