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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.

Publication ,  Journal Article
Ajani, JA; Winter, K; Komaki, R; Kelsen, DP; Minsky, BD; Liao, Z; Bradley, J; Fromm, M; Hornback, D; Willett, CG
Published in: J Clin Oncol
October 1, 2008

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 >or= 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.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

October 1, 2008

Volume

26

Issue

28

Start / End Page

4551 / 4556

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Radiotherapy Dosage
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans
  • Fluorouracil
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Ajani, J. A., Winter, K., Komaki, R., Kelsen, D. P., Minsky, B. D., Liao, Z., … Willett, C. G. (2008). Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113. J Clin Oncol, 26(28), 4551–4556. https://doi.org/10.1200/JCO.2008.16.6918
Ajani, Jaffer A., Kathryn Winter, Ritsuko Komaki, David P. Kelsen, Bruce D. Minsky, Zhongxing Liao, Jeffrey Bradley, Mitchel Fromm, David Hornback, and Christopher G. Willett. “Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113.J Clin Oncol 26, no. 28 (October 1, 2008): 4551–56. https://doi.org/10.1200/JCO.2008.16.6918.
Ajani, Jaffer A., et al. “Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113.J Clin Oncol, vol. 26, no. 28, Oct. 2008, pp. 4551–56. Pubmed, doi:10.1200/JCO.2008.16.6918.
Ajani JA, Winter K, Komaki R, Kelsen DP, Minsky BD, Liao Z, Bradley J, Fromm M, Hornback D, Willett CG. Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113. J Clin Oncol. 2008 Oct 1;26(28):4551–4556.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

October 1, 2008

Volume

26

Issue

28

Start / End Page

4551 / 4556

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Radiotherapy Dosage
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans
  • Fluorouracil
  • Female