Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113 Journal Article


Authors: Ajani, J. A.; Winter, K.; Komaki, R.; Kelsen, D. P.; Minsky, B. D.; Liao, Z. X.; Bradley, J.; Fromm, M.; Hornback, D.; Willett, C. G.
Article Title: Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113
Abstract: 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.
Keywords: cisplatin; fluorouracil; paclitaxel; adenocarcinoma; surgery; chemoradiotherapy; sensitivity; combined-modality therapy; x-ray; cancer statistics; concurrent radiation-therapy
Journal Title: Journal of Clinical Oncology
Volume: 26
Issue: 28
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2008-10-01
Start Page: 4551
End Page: 4556
Language: English
ACCESSION: WOS:000259648300009
DOI: 10.1200/jco.2008.16.6918
PROVIDER: wos
PMCID: PMC2653130
PUBMED: 18574157
Notes: --- - Article - "Source: Wos"
Altmetric Score
MSK Authors
  1. Bruce Minsky
    264 Minsky
  2. David P Kelsen
    341 Kelsen