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Journal of Clinical Oncology, Vol 19, Issue 2 (January), 2001: 305-313
© 2001 American Society for Clinical Oncology

Randomized Trial of Preoperative Chemoradiation Versus Surgery Alone in Patients With Locoregional Esophageal Carcinoma

By Susan G. Urba, Mark B. Orringer, Andrew Turrisi, Mark Iannettoni, Arlene Forastiere, Myla Strawderman

From the University of Michigan Medical Center, Ann Arbor, MI.

Address reprint requests to Susan G. Urba, MD, University of Michigan Medical Center, 1500 E Medical Center Dr, 1366 Cancer Center, Ann Arbor, MI 48109; email surba{at}umich.edu

PURPOSE: A pilot study of 43 patients with potentially resectable esophageal carcinoma treated with an intensive regimen of preoperative chemoradiation with cisplatin, fluorouracil, and vinblastine before surgery showed a median survival of 29 months in comparison with the 12-month median survival of 100 historical controls treated with surgery alone at the same institution. We designed a randomized trial to compare survival for patients treated with this preoperative chemoradiation regimen versus surgery alone.

MATERIALS AND METHODS: One hundred patients with esophageal carcinoma were randomized to receive either surgery alone (arm I) or preoperative chemoradiation (arm II) with cisplatin 20 mg/m2/d on days 1 through 5 and 17 through 21, fluorouracil 300 mg/m2/d on days 1 through 21, and vinblastine 1 mg/m2/d on days 1 through 4 and 17 through 20. Radiotherapy consisted of 1.5-Gy fractions twice daily, Monday through Friday over 21 days, to a total dose of 45 Gy. Transhiatal esophagectomy with a cervical esophagogastric anastomosis was performed on approximately day 42.

RESULTS: At median follow-up of 8.2 years, there is no significant difference in survival between the treatment arms. Median survival is 17.6 months in arm I and 16.9 months in arm II. Survival at 3 years was 16% in arm I and 30% in arm II (P = .15). This study was statistically powered to detect a relatively large increase in median survival from 1 year to 2.2 years, with at least 80% power.

CONCLUSION: This randomized trial of preoperative chemoradiation versus surgery alone for patients with potentially resectable esophageal carcinoma did not demonstrate a statistically significant survival difference.


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J. Johansson, T. R. DeMeester, J. A. Hagen, S. R. DeMeester, J. H. Peters, S. Oberg, and C. G. Bremner
En Bloc vs Transhiatal Esophagectomy for Stage T3 N1 Adenocarcinoma of the Distal Esophagus
Arch Surg, June 1, 2004; 139(6): 627 - 633.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
U. Warnecke-Eberz, R. Metzger, F. Miyazono, S. E. Baldus, S. Neiss, J. Brabender, H. Schaefer, W. Doerfler, E. Bollschweiler, H. P. Dienes, et al.
High Specificity of Quantitative Excision Repair Cross-Complementing 1 Messenger RNA Expression for Prediction of Minor Histopathological Response to Neoadjuvant Radiochemotherapy in Esophageal Cancer
Clin. Cancer Res., June 1, 2004; 10(11): 3794 - 3799.
[Abstract] [Full Text] [PDF]

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 Arch SurgHome page
S. C. Malaisrie, B. Untch, G. V. Aranha, N. Mohideen, A. Hantel, and J. Pickleman
Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Cancer: Experience at a Single Institution
Arch Surg, May 1, 2004; 139(5): 532 - 539.
[Abstract] [Full Text] [PDF]

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 Ann. Thorac. Surg.Home page
J. S. Donington, D. L. Miller, M. S. Allen, C. Deschamps, F. C. Nichols III, and P. C. Pairolero
Preoperative chemoradiation therapy does not improve early survival after esophagectomy for patients with clinical stage III adenocarcinoma of the esophagus
Ann. Thorac. Surg., April 1, 2004; 77(4): 1193 - 1199.
[Abstract] [Full Text] [PDF]

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 Crit Care NurseHome page
D. J. Mackenzie, P. K. Popplewell, and K. G. Billingsley
Care of Patients After Esophagectomy
Crit. Care Nurse, February 1, 2004; 24(1): 16 - 29.
[Full Text] [PDF]

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 JCOHome page
B. Brenner, D. H. Ilson, B. D. Minsky, M. S. Bains, W. Tong, M. Gonen, and D. P. Kelsen
Phase I Trial of Combined-Modality Therapy for Localized Esophageal Cancer: Escalating Doses of Continuous-Infusion Paclitaxel With Cisplatin and Concurrent Radiation Therapy
J. Clin. Oncol., January 1, 2004; 22(1): 45 - 52.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
A. Alidina, A. Gaffar, F. Hussain, M. Islam, I. Vaziri, I. Burney, A. Valimohd, and W. Jafri
Survival data and prognostic factors seen in Pakistani patients with esophageal cancer
Ann. Onc., January 1, 2004; 15(1): 118 - 122.
[Abstract] [Full Text] [PDF]

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 JCOHome page
N. Ando, T. Iizuka, H. Ide, K. Ishida, M. Shinoda, T. Nishimaki, W. Takiyama, H. Watanabe, K. Isono, N. Aoyama, et al.
Surgery Plus Chemotherapy Compared With Surgery Alone for Localized Squamous Cell Carcinoma of the Thoracic Esophagus: A Japan Clinical Oncology Group Study--JCOG9204
J. Clin. Oncol., December 15, 2003; 21(24): 4592 - 4596.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
M. K. Gibson, S. C. Abraham, T.-T. Wu, B. Burtness, R. F. Heitmiller, E. Heath, and A. Forastiere
Epidermal Growth Factor Receptor, p53 Mutation, and Pathological Response Predict Survival in Patients with Locally Advanced Esophageal Cancer Treated with Preoperative Chemoradiotherapy
Clin. Cancer Res., December 15, 2003; 9(17): 6461 - 6468.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
P. C. Enzinger and R. J. Mayer
Esophageal Cancer
N. Engl. J. Med., December 4, 2003; 349(23): 2241 - 2252.
[Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
T. W. Rice, D. J. Adelstein, M. A. Chidel, L. A. Rybicki, M. M. DeCamp, S. C. Murthy, and E. H. Blackstone
Benefit of postoperative adjuvant chemoradiotherapy in locoregionally advanced esophageal carcinoma
J. Thorac. Cardiovasc. Surg., November 1, 2003; 126(5): 1590 - 1596.
[Abstract] [Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
R. S. Keresztes, J. L. Port, M. W. Pasmantier, R. J. Korst, and N. K. Altorki
Preoperative chemotherapy for esophageal cancer with paclitaxel and carboplatin: Results of a phase II trial
J. Thorac. Cardiovasc. Surg., November 1, 2003; 126(5): 1603 - 1608.
[Abstract] [Full Text] [PDF]

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 JCOHome page
S.J. Darnton, V.R. Archer, D.D. Stocken, P.J. Mulholland, A.G. Casson, and D.R. Ferry
Preoperative Mitomycin, Ifosfamide, and Cisplatin Followed by Esophagectomy in Squamous Cell Carcinoma of the Esophagus: Pathologic Complete Response Induced by Chemotherapy Leads to Long-Term Survival
J. Clin. Oncol., November 1, 2003; 21(21): 4009 - 4015.
[Abstract] [Full Text] [PDF]

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 Eur. J. Cardiothorac. Surg.Home page
J. S. Donington, D. L. Miller, M. S. Allen, C. Deschamps, F. C. Nichols III, and P. C. Pairolero
Tumor response to induction chemoradiation: influence on survival after esophagectomy
Eur. J. Cardiothorac. Surg., October 1, 2003; 24(4): 631 - 637.
[Abstract] [Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
S. R. DeMeester
Lymph node involvement in esophageal adenocarcinoma: if you see one, have you seen them all?
J. Thorac. Cardiovasc. Surg., October 1, 2003; 126(4): 947 - 949.
[Full Text] [PDF]

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 JCOHome page
D. H. Ilson, M. Bains, D. P. Kelsen, E. O'Reilly, M. Karpeh, D. Coit, V. Rusch, M. Gonen, K. Wilson, and B. D. Minsky
Phase I Trial of Escalating-Dose Irinotecan Given Weekly With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal Cancer
J. Clin. Oncol., August 1, 2003; 21(15): 2926 - 2932.
[Abstract] [Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
J. A. Hagen and T. R. DeMeester
Staging of esophageal carcinoma
J. Thorac. Cardiovasc. Surg., May 1, 2003; 125(5): 988 - 991.
[Full Text] [PDF]

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 NEJMHome page
H. M. Kocher, P. P. Tekkis, J. P.S. Knisely, B. A. Burtness, R. R. Salem, J. J. B. van Lanschot, H. W. Tilanus, H. Obertop, M. Kitajima, Y. Kitagawa, et al.
Surgical Treatment of Esophageal Cancer
N. Engl. J. Med., March 20, 2003; 348(12): 1177 - 1179.
[Full Text] [PDF]

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 JCOHome page
R. J. Downey, T. Akhurst, D. Ilson, R. Ginsberg, M. S. Bains, M. Gonen, H. Koong, M. Gollub, B. D. Minsky, M. Zakowski, et al.
Whole Body 18FDG-PET and the Response of Esophageal Cancer to Induction Therapy: Results of a Prospective Trial
J. Clin. Oncol., February 1, 2003; 21(3): 428 - 432.
[Abstract] [Full Text] [PDF]

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 Ann. Thorac. Surg.Home page
S. H. Bailey, D. A. Bull, D. H. Harpole, J. J. Rentz, L. A. Neumayer, T. N. Pappas, J. Daley, W. G. Henderson, B. Krasnicka, and S. F. Khuri
Outcomes after esophagectomy: a ten-year prospective cohort
Ann. Thorac. Surg., January 1, 2003; 75(1): 217 - 222.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
J. S. Waters, D. Tait, D. Cunningham, A. R. Padhani, M. E. Hill, S. Falk, F. Lofts, A. Norman, J. Oates, and A. Hill
A multicentre phase II trial of primary chemotherapy with cisplatin and protracted venous infusion 5-fluorouracil followed by chemoradiation in patients with carcinoma of the oesophagus
Ann. Onc., November 1, 2002; 13(11): 1763 - 1770.
[Abstract] [Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
M. S. Bains, A. Stojadinovic, B. Minsky, V. Rusch, A. Turnbull, R. Korst, R. Ginsberg, D. P. Kelsen, and D. H. Ilson
A phase II trial of preoperative combined-modality therapy for localized esophageal carcinoma: Initial results
J. Thorac. Cardiovasc. Surg., August 1, 2002; 124(2): 270 - 277.
[Abstract] [Full Text] [PDF]

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 Ann. Thorac. Surg.Home page
J. R. Doty, J. D. Salazar, A. A. Forastiere, E. I. Heath, L. Kleinberg, and R. F. Heitmiller
Postesophagectomy morbidity, mortality, and length of hospital stay after preoperative chemoradiation therapy
Ann. Thorac. Surg., July 1, 2002; 74(1): 227 - 231.
[Abstract] [Full Text] [PDF]

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 JCOHome page
C. G. Willett
Radiation Dose Escalation in Combined-Modality Therapy for Esophageal Cancer
J. Clin. Oncol., March 1, 2002; 20(5): 1151 - 1153.
[Full Text] [PDF]

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 Ann. Thorac. Surg.Home page
J. W.C. Entwistle III and M. Goldberg
Multimodality therapy for resectable cancer of the thoracic esophagus
Ann. Thorac. Surg., March 1, 2002; 73(3): 1009 - 1015.
[Abstract] [Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
S. G. Swisher, P. Wynn, J. B. Putnam, M. B. Mosheim, A. M. Correa, R. R. Komaki, J. A. Ajani, W. R. Smythe, A. A. Vaporciyan, J. A. Roth, et al.
Salvage esophagectomy for recurrent tumors after definitive chemotherapy and radiotherapy
J. Thorac. Cardiovasc. Surg., January 1, 2002; 123(1): 175 - 183.
[Abstract] [Full Text] [PDF]

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 Ann. Thorac. Surg.Home page
J. A. Hagen and T. R. DeMeester
Esophageal adenocarcinoma
Ann. Thorac. Surg., October 1, 2001; 72(4): 1430 - 1432.
[Full Text] [PDF]

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 Arch SurgHome page
J. I. Lew, W. E. Gooding, U. Ribeiro Jr, A. V. Safatle-Ribeiro, and M. C. Posner
Long-term Survival Following Induction Chemoradiotherapy and Esophagectomy for Esophageal Carcinoma
Arch Surg, July 1, 2001; 136(7): 737 - 742.
[Abstract] [Full Text] [PDF]


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