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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03234842
Other study ID # UFPTI 1605-ES01
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date October 30, 2017
Est. completion date December 11, 2018

Study information

Verified date December 2018
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 11, 2018
Est. primary completion date December 11, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Proton Beam Therapy
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Photon Radiation Therapy
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
Drug:
Chemotherapy
Concurrent weekly chemotherapy at standard doses

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 (40)

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. — View Citation

Bedenne L, Michel P, Bouché O, Milan C, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Herr JP, Paillot B, Arveux P, Bonnetain F, Binquet C. Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus: FFCD 9102. J Clin Oncol. 2007 Apr 1;25(10):1160-8. — View Citation

Blazeby JM, Conroy T, Hammerlid E, Fayers P, Sezer O, Koller M, Arraras J, Bottomley A, Vickery CW, Etienne PL, Alderson D; European Organisation for Research and Treatement of Cancer Gastrointestinal and Quality of Life Groups. Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer. Eur J Cancer. 2003 Jul;39(10):1384-94. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Derogar M, Lagergren P. Health-related quality of life among 5-year survivors of esophageal cancer surgery: a prospective population-based study. J Clin Oncol. 2012 Feb 1;30(4):413-8. doi: 10.1200/JCO.2011.38.9791. Epub 2012 Jan 3. — View Citation

Donahue JM, Nichols FC, Li Z, Schomas DA, Allen MS, Cassivi SD, Jatoi A, Miller RC, Wigle DA, Shen KR, Deschamps C. Complete pathologic response after neoadjuvant chemoradiotherapy for esophageal cancer is associated with enhanced survival. Ann Thorac Surg. 2009 Feb;87(2):392-8; discussion 398-9. doi: 10.1016/j.athoracsur.2008.11.001. — View Citation

Donohoe CL, McGillycuddy E, Reynolds JV. Long-term health-related quality of life for disease-free esophageal cancer patients. World J Surg. 2011 Aug;35(8):1853-60. doi: 10.1007/s00268-011-1123-6. — View Citation

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. — View Citation

Ferguson MK, Celauro AD, Prachand V. Prediction of major pulmonary complications after esophagectomy. Ann Thorac Surg. 2011 May;91(5):1494-1500; discussion 1500-1. doi: 10.1016/j.athoracsur.2010.12.036. — View Citation

Ferguson MK, Durkin AE. Preoperative prediction of the risk of pulmonary complications after esophagectomy for cancer. J Thorac Cardiovasc Surg. 2002 Apr;123(4):661-9. — View Citation

Gergel TJ, Leichman L, Nava HR, Blumenson LE, Loewen GM, Gibbs JE, Khushalani NI, Leichman CG, Bodnar LM, Douglass HO, Smith JL, Kuettel MR, Proulx GM. Effect of concurrent radiation therapy and chemotherapy on pulmonary function in patients with esophageal cancer: dose-volume histogram analysis. Cancer J. 2002 Nov-Dec;8(6):451-60. — View Citation

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. Erratum in: J Clin Oncol 1992 Nov;10(11):1822. — View Citation

Hurmuzlu M, Aarstad HJ, Aarstad AK, Hjermstad MJ, Viste A. Health-related quality of life in long-term survivors after high-dose chemoradiotherapy followed by surgery in esophageal cancer. Dis Esophagus. 2011 Jan;24(1):39-47. doi: 10.1111/j.1442-2050.2010.01104.x. Epub 2010 Sep 2. — View Citation

Kachnic LA, Winter K, Wasserman T, Kelsen D, Ginsberg R, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Willett CG, Minsky BD. Longitudinal Quality-of-Life Analysis of RTOG 94-05 (Int 0123):A Phase III Trial of Definitive Chemoradiotherapy for Esophageal Cancer. Gastrointest Cancer Res. 2011 Mar;4(2):45-52. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Lund M, Alexandersson von Döbeln G, Nilsson M, Winter R, Lundell L, Tsai JA, Kalman S. Effects on heart function of neoadjuvant chemotherapy and chemoradiotherapy in patients with cancer in the esophagus or gastroesophageal junction - a prospective cohort pilot study within a randomized clinical trial. Radiat Oncol. 2015 Jan 13;10:16. doi: 10.1186/s13014-014-0310-7. — View Citation

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. — View Citation

Marks LB, Fan M, Clough R, Munley M, Bentel G, Coleman RE, Jaszczak R, Hollis D, Anscher M. Radiation-induced pulmonary injury: symptomatic versus subclinical endpoints. Int J Radiat Biol. 2000 Apr;76(4):469-75. — View Citation

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. — View Citation

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. — View Citation

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7. — View Citation

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. — View Citation

Stahl M, Stuschke M, Lehmann N, Meyer HJ, Walz MK, Seeber S, Klump B, Budach W, Teichmann R, Schmitt M, Schmitt G, Franke C, Wilke H. Chemoradiation with and without surgery in patients with locally advanced squamous cell carcinoma of the esophagus. J Clin Oncol. 2005 Apr 1;23(10):2310-7. Erratum in: J Clin Oncol. 2006 Jan 20;24(3):531. — View Citation

Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92. doi: 10.1200/JCO.2007.12.9593. — View Citation

van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088. — View Citation

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

von Döbeln GA, Nilsson M, Adell G, Johnsen G, Hatlevoll I, Tsai J, Lundell L, Lund M, Lind P. Pulmonary function and cardiac stress test after multimodality treatment of esophageal cancer. Pract Radiat Oncol. 2016 May-Jun;6(3):e53-e59. doi: 10.1016/j.prro.2015.10.015. Epub 2015 Nov 10. — View Citation

Walsh TN, Noonan N, Hollywood D, Kelly A, Keeling N, Hennessy TP. A comparison of multimodal therapy and surgery for esophageal adenocarcinoma. N Engl J Med. 1996 Aug 15;335(7):462-7. Erratum in: N Engl J Med 1999 Jul 29;341(5):384. — View Citation

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 J, Wei C, Tucker SL, Myles B, Palmer M, Hofstetter WL, Swisher SG, Ajani JA, Cox JD, Komaki R, Liao Z, Lin SH. Predictors of postoperative complications after trimodality therapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2013 Aug 1;86(5):885-91. doi: 10.1016/j.ijrobp.2013.04.006. — View Citation

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. Epub 2005 Oct 19. — View Citation

Warren S, Partridge M, Carrington R, Hurt C, Crosby T, Hawkins MA. Radiobiological determination of dose escalation and normal tissue toxicity in definitive chemoradiation therapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):423-9. doi: 10.1016/j.ijrobp.2014.06.028. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 40 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy Approximately 12 months after radiation therapy
Secondary Compare quality of life 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 Approximately 12 months after radiation therapy
Secondary Compare outcomes for local control 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 Approximately 12 months after radiation therapy
Secondary Compare outcomes for progression free survival 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 Approximately 12 months after radiation therapy
Secondary Compare overall survival rates 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 Approximately 12 months after radiation therapy
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