Originally published as JCO Early Release 10.1200/JCO.2008.16.6918 on June 23 2008

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Phase II Randomized Trial of Two Nonoperative Regimens of Induction Chemotherapy Followed by Chemoradiation in Patients With Localized Carcinoma of the Esophagus: RTOG 0113

Jaffer A. Ajani, Kathryn Winter, Ritsuko Komaki, David P. Kelsen, Bruce D. Minsky, Zhongxing Liao, Jeffrey Bradley, Mitchel Fromm, David Hornback, Christopher G. Willett

From The University of Texas M. D. Anderson Cancer Center, Houston, TX; Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Memorial Sloan-Kettering Cancer Center, New York, NY; Washington University, St Louis, MO; Akron General Medical Center, Akron, OH; Northern Indiana Cancer Consortium, Mishawaka, IN; and Duke University Medical Center, Durham, NC

Corresponding author: Jaffer A. Ajani, MD, Department of Gastrointestinal Medical Oncology, Mail Stop: 426, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030; e-mail: jajani{at}mdanderson.org

Purpose Two nonoperative approaches (one without fluorouracil) using induction chemotherapy and then definitive chemoradiotherapy developed at two centers were compared in patients with localized esophageal cancer (LEC). The primary end point was to assess whether any approach would achieve a 77.5% 1-year survival rate, surpassing the historical 66% rate from the Radiation Therapy Oncology Group (RTOG) protocol 9405.

Patients and Methods In a multi-institutional cooperative group setting, patients with LEC who had unresectable cancer, were unwilling to undergo surgery, or were medically unfit for surgery were randomly assigned to receive either induction with fluorouracil, cisplatin, and paclitaxel and then fluorouracil plus paclitaxel with 50.4 Gy of radiation (arm A) or induction with paclitaxel plus cisplatin and then the same chemotherapy with 50.4 Gy of radiation (arm B). Safety and survival rates were assessed.

Results A total of 84 patients were randomly assigned (arm A, n = 41; arm B, n = 43), and 72 were assessable (arm A, n = 37; arm B, n = 35). The median survival time was 28.7 months for patients in arm A and 14.9 months for patients in arm B (18.8 months for patients in RTOG 9405). The 1-year survival rate of 75.7% in arm A was close to, but did not meet or surpass, the 77.5% goal. The 2-year survival rate was 56% for arm A and 37% for arm B. Grade 3 (arm A = 54%, arm B = 43%) and grade 4 toxicities (arm A = 27%, arm B = 40%) were frequent. Treatment-related death occurred in 3% of patients in arm A and 6% of patients in arm B.

Conclusion Both arms of RTOG 0113 were associated with high morbidity, and the study did not meet its 1-year survival end point.

published online ahead of print at www.jco.org on June 23, 2008

Supported by Grant Nos. CA21661, CA37422, and 32115 from the National Cancer Institute.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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