Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer (ES01)
19. december 2018 opdateret af: University of Florida
A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer
This study will evaluate if proton beam therapy as part of chemoradiation results in a decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation therapy for esophageal carcinoma.
A secondary objective is to determine effects on cardiac function, quality of life, and compare acute and late toxicities.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Radiation Modality: Proton radiotherapy will be offered to all patients that meet trial eligibility. If patients decline proton radiotherapy or are otherwise unable to receive proton therapy they will be included in x-ray cohort (group 2).
Chemotherapy will be delivered at the discretion of the treating Medical Oncologist. Weekly carboplatin and paclitaxel at standard doses is preferred. It is recommended that the weekly chemotherapy regimen be continued throughout the course of radiotherapy. Chemotherapy should begin within 48 hours of beginning radiotherapy.
Undersøgelsestype
Interventionel
Fase
- Fase 2
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
Beskrivelse
Inclusion Criteria:
- Patient must be at least 18 years at the time of consent.
- Pathologically confirmed esophageal adenocarcinoma or squamous cell. carcinoma of the thoracic esophagus or esophagogastric junction.
- Patient's preliminary cancer stage, according to the AJCC 7th edition staging, must be cT1b-T4, N0-N3.
Exclusion Criteria:
- Patients with cervical esophageal carcinoma.
- Prior radiotherapy with fields overlapping the current esophageal cancer.
- Patients with cT1a disease.
- Patients with evidence of tracheoesophageal fistula must undergo bronchoscopy to exclude fistula.
- Patients with distant metastatic disease.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Proton
Proton beam therapy of 59.4 Gy in 1.8 Gy fractions (50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
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59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Andre navne:
Concurrent weekly chemotherapy at standard doses
Andre navne:
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Aktiv komparator: Photon
Photon Radiation therapy of 59.4 Gy in 1.8Gy fractions ( 50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
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Concurrent weekly chemotherapy at standard doses
Andre navne:
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Compare the rate of a clinically significant reduction of DLCO (defined as a decrease of ≥ 10% from baseline) between protons and photons after preoperative or definitive chemoradiation
Tidsramme: Approximately 12 months after radiation therapy
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Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Compare quality of life
Tidsramme: Approximately 12 months after radiation therapy
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Participants quality of life results using EORTC Quality of Life Questionnaire - Oesophageal Cancer Module (OES-18) and EORTC QLQ C-30 conjointly approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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Compare outcomes for local control
Tidsramme: Approximately 12 months after radiation therapy
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Number of participants with local control for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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Compare outcomes for progression free survival
Tidsramme: Approximately 12 months after radiation therapy
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Number of participants with progression free survival for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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Compare overall survival rates
Tidsramme: Approximately 12 months after radiation therapy
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Number of participants with overall survival rates for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Michael Rutenberg, MD, PhD, UF Health Proton Therapy Institute
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
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- Lee HK, Vaporciyan AA, Cox JD, Tucker SL, Putnam JB Jr, Ajani JA, Liao Z, Swisher SG, Roth JA, Smythe WR, Walsh GL, Mohan R, Liu HH, Mooring D, Komaki R. Postoperative pulmonary complications after preoperative chemoradiation for esophageal carcinoma: correlation with pulmonary dose-volume histogram parameters. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1317-22. doi: 10.1016/s0360-3016(03)01373-7.
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- De Jaeger K, Seppenwoolde Y, Boersma LJ, Muller SH, Baas P, Belderbos JS, Lebesque JV. Pulmonary function following high-dose radiotherapy of non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2003 Apr 1;55(5):1331-40. doi: 10.1016/s0360-3016(02)04389-4.
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- Lopez Guerra JL, Gomez DR, Zhuang Y, Levy LB, Eapen G, Liu H, Mohan R, Komaki R, Cox JD, Liao Z. Changes in pulmonary function after three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, or proton beam therapy for non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):e537-43. doi: 10.1016/j.ijrobp.2012.01.019. Epub 2012 Mar 13.
- Miller KL, Zhou SM, Barrier RC Jr, Shafman T, Folz RJ, Clough RW, Marks LB. Long-term changes in pulmonary function tests after definitive radiotherapy for lung cancer. Int J Radiat Oncol Biol Phys. 2003 Jul 1;56(3):611-5. doi: 10.1016/s0360-3016(03)00182-2.
- Enache I, Noel G, Jeung MY, Meyer N, Oswald-Mammosser M, Pistea C, Jung GM, Mennecier B, Quoix E, Charloux A. Impact of 3D conformal radiotherapy on lung function of patients with lung cancer: a prospective study. Respiration. 2013;86(2):100-8. doi: 10.1159/000342371. Epub 2012 Nov 13.
- Borst GR, De Jaeger K, Belderbos JS, Burgers SA, Lebesque JV. Pulmonary function changes after radiotherapy in non-small-cell lung cancer patients with long-term disease-free survival. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):639-44. doi: 10.1016/j.ijrobp.2004.11.029.
- Lin FC, Durkin AE, Ferguson MK. Induction therapy does not increase surgical morbidity after esophagectomy for cancer. Ann Thorac Surg. 2004 Nov;78(5):1783-9. doi: 10.1016/j.athoracsur.2004.04.081.
- Cerfolio RJ, Talati A, Bryant AS. Changes in pulmonary function tests after neoadjuvant therapy predict postoperative complications. Ann Thorac Surg. 2009 Sep;88(3):930-5; discussion 935-6. doi: 10.1016/j.athoracsur.2009.06.013.
- Gill PG, Denham JW, Jamieson GG, Devitt PG, Yeoh E, Olweny C. Patterns of treatment failure and prognostic factors associated with the treatment of esophageal carcinoma with chemotherapy and radiotherapy either as sole treatment or followed by surgery. J Clin Oncol. 1992 Jul;10(7):1037-43. doi: 10.1200/JCO.1992.10.7.1037. Erratum In: J Clin Oncol 1992 Nov;10(11):1822.
- Chirieac LR, Swisher SG, Ajani JA, Komaki RR, Correa AM, Morris JS, Roth JA, Rashid A, Hamilton SR, Wu TT. Posttherapy pathologic stage predicts survival in patients with esophageal carcinoma receiving preoperative chemoradiation. Cancer. 2005 Apr 1;103(7):1347-55. doi: 10.1002/cncr.20916.
- Meredith KL, Weber JM, Turaga KK, Siegel EM, McLoughlin J, Hoffe S, Marcovalerio M, Shah N, Kelley S, Karl R. Pathologic response after neoadjuvant therapy is the major determinant of survival in patients with esophageal cancer. Ann Surg Oncol. 2010 Apr;17(4):1159-67. doi: 10.1245/s10434-009-0862-1. Epub 2010 Feb 6.
- Bosset JF, Gignoux M, Triboulet JP, Tiret E, Mantion G, Elias D, Lozach P, Ollier JC, Pavy JJ, Mercier M, Sahmoud T. Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus. N Engl J Med. 1997 Jul 17;337(3):161-7. doi: 10.1056/NEJM199707173370304.
- Yoon DH, Jang G, Kim JH, Kim YH, Kim JY, Kim HR, Jung HY, Lee GH, Song HY, Cho KJ, Ryu JS, Kim SB. Randomized phase 2 trial of S1 and oxaliplatin-based chemoradiotherapy with or without induction chemotherapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):489-96. doi: 10.1016/j.ijrobp.2014.11.019. Epub 2015 Jan 30.
- Spigel DR, Greco FA, Meluch AA, Lane CM, Farley C, Gray JR, Clark BL, Burris HA 3rd, Hainsworth JD. Phase I/II trial of preoperative oxaliplatin, docetaxel, and capecitabine with concurrent radiation therapy in localized carcinoma of the esophagus or gastroesophageal junction. J Clin Oncol. 2010 May 1;28(13):2213-9. doi: 10.1200/JCO.2009.24.8773. Epub 2010 Mar 29.
- Ajani JA, Xiao L, Roth JA, Hofstetter WL, Walsh G, Komaki R, Liao Z, Rice DC, Vaporciyan AA, Maru DM, Lee JH, Bhutani MS, Eid A, Yao JC, Phan AP, Halpin A, Suzuki A, Taketa T, Thall PF, Swisher SG. A phase II randomized trial of induction chemotherapy versus no induction chemotherapy followed by preoperative chemoradiation in patients with esophageal cancer. Ann Oncol. 2013 Nov;24(11):2844-9. doi: 10.1093/annonc/mdt339. Epub 2013 Aug 23.
- Venkat P, Shridhar R, Naghavi A, et al. Pathologic Complete Response and Dose Escalation with Preoperative Dose Painting IMRT Chemoradiation in Esophageal Cancer. IJROBP. 2015; 93:S219-220
- Makishima H, Ishikawa H, Terunuma T, Hashimoto T, Yamanashi K, Sekiguchi T, Mizumoto M, Okumura T, Sakae T, Sakurai H. Comparison of adverse effects of proton and X-ray chemoradiotherapy for esophageal cancer using an adaptive dose-volume histogram analysis. J Radiat Res. 2015 May;56(3):568-76. doi: 10.1093/jrr/rrv001. Epub 2015 Mar 9.
- Wang J, Palmer M, Bilton SD, et al. Comparing Proton Beam to Intensity Modulated Radiation Therapy Planning in Esophageal Cancer. Int J Particle Ther. 2015;1:866-877.
- Wang SL, Liao Z, Vaporciyan AA, Tucker SL, Liu H, Wei X, Swisher S, Ajani JA, Cox JD, Komaki R. Investigation of clinical and dosimetric factors associated with postoperative pulmonary complications in esophageal cancer patients treated with concurrent chemoradiotherapy followed by surgery. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):692-9. doi: 10.1016/j.ijrobp.2005.08.002. Epub 2005 Oct 19.
- Wei X, Liu HH, Tucker SL, Wang S, Mohan R, Cox JD, Komaki R, Liao Z. Risk factors for pericardial effusion in inoperable esophageal cancer patients treated with definitive chemoradiation therapy. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):707-14. doi: 10.1016/j.ijrobp.2007.10.056. Epub 2008 Jan 11.
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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 (Faktiske)
30. oktober 2017
Primær færdiggørelse (Faktiske)
11. december 2018
Studieafslutning (Faktiske)
11. december 2018
Datoer for studieregistrering
Først indsendt
21. juli 2017
Først indsendt, der opfyldte QC-kriterier
26. juli 2017
Først opslået (Faktiske)
31. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Esophageale neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Carboplatin
- Paclitaxel
Andre undersøgelses-id-numre
- UFPTI 1605-ES01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ja
produkt fremstillet i og eksporteret fra U.S.A.
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Kliniske forsøg med Spiserørskræft
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Assiut UniversityIkke rekrutterer endnu
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The Methodist Hospital Research InstituteAfsluttetEsophageal eller gastrisk perforering | Esophageal eller gastrisk lækageForenede Stater
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Federal University of São PauloUkendtEsophageal forsnævring | Ætsende esophageal forsnævring | Peptisk esophageal forsnævring | Post-kirurgisk esophageal strikturBrasilien
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Mayo ClinicNational Cancer Institute (NCI)AfsluttetStadie III lungekræft AJCC v8 | Stadie II lungekræft AJCC v8 | Stadie IIA lungekræft AJCC v8 | Stadie IIB lungekræft AJCC v8 | Stadie IIIA Lungekræft AJCC v8 | Stadie IIIB Lungekræft AJCC v8 | Stadie I lungekræft AJCC v8 | Stadie IA1 Lungekræft AJCC v8 | Stadie IA2 Lungekræft AJCC v8 | Stadie IA3 lungekræft... og andre forholdForenede Stater
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Johns Hopkins UniversityTrukket tilbageEsophageal Perforation | Esophageal fistel | Forsnævring af spiserøret | Esophageal lækage | Endostitch | Esophageal stentForenede Stater
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Boston Children's HospitalChildren's Hospital of PhiladelphiaRekrutteringEsophageal atresi | Forsnævring af spiserøret | Esophageal atresi med tracheo-esophageal fistelForenede Stater
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Shaare Zedek Medical CenterEuropean Society of Pediatric Gastroenterology, Hepatology and NutritionIkke rekrutterer endnuEsophageal forsnævringIsrael
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UMC UtrechtJulius Centre for Health Sciences and Primary Care, UMC UtrechtRekrutteringEsophageal Adenocarcinom | Esophageal Adenocarcinom (EAC) | Adenocarcinom - Gastroøsofageal Junction (GEJ)Holland
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Mayo ClinicAfsluttetEsophageal Dilatation | Refraktær benign esophageal forsnævringForenede Stater
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The Cleveland ClinicMedtronic - MITGAfsluttetEsophageal læsionForenede Stater
Kliniske forsøg med Proton Beam Therapy
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Ion Beam ApplicationsAktiv, ikke rekrutterende
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Ion Beam ApplicationsAktiv, ikke rekrutterende
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Ion Beam ApplicationsAktiv, ikke rekrutterende
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Thompson Cancer Survival CenterRekrutteringBrystkræft | Brystkræft fase I | Brystkræft fase II | Brystkræft fase IIIForenede Stater
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The New York Proton CenterRekrutteringBrystkræft | Hoved- og halskræft | Gynækologisk kræft | Prostatakræft | Thoraxkræft | CNS kræft | GI-kræftForenede Stater
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University of Maryland, BaltimoreAktiv, ikke rekrutterendeHoved- og halskræft | Orofarynx pladecellekarcinom | Oropharynx CancerForenede Stater
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Washington University School of MedicineAfsluttetTilbagevendende endetarmskræftForenede Stater
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The New York Proton CenterAktiv, ikke rekrutterendeProstatakræftForenede Stater
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Sidney Kimmel Comprehensive Cancer Center at Johns...Aktiv, ikke rekrutterendeMelanom | SarkomForenede Stater
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Stanford UniversityAfsluttetMycosis Fungoides | Lymfomer: Non-Hodgkin | Lymfomer: Non-Hodgkin perifer T-celle | Lymfomer: Non-Hodgkin kutan lymfomForenede Stater