INT 0123 (Radiation therapy oncology group 94-05) phase III trial of combined-modality therapy for esophageal cancer: High-dose versus standard-dose radiation therapy

Bruce D. Minsky, Thomas F. Pajak, Robert J. Ginsberg, Thomas M. Pisansky, James Martenson, Ritsuko Komaki, Gordon Okawara, Seth A. Rosenthal, David P. Kelsen

Research output: Contribution to journalArticle

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Abstract

Purpose: To compare the local/regional control, survival, and toxicity of combined-modality therapy using high-dose (64.8 Gy) versus standard-dose (50.4 Gy) radiation therapy for the treatment of patients with esophageal cancer. Patients and Methods: A total of 236 patients with clinical stage T1 to T4, N0/1, M0 squamous cell carcinoma or adenocarcinoma selected for a nonsurgical approach, after stratification by weight loss, primary tumor size, and histology, were randomized to receive combined-modality therapy consisting of four monthly cycles of fluorouracil (5-FU) (1,000 mg/m2/24 hours for 4 days) and cisplatin (75 mg/m2 bolus day 1) with concurrent 64.8 Gy versus the same chemotherapy schedule but with concurrent 50.4 Gy. The trial was stopped after an interim analysis. The median follow-up was 16.4 months for all patients and 29.5 months for patients still alive. Results: For the 218 eligible patients, there was no significant difference in median survival (13.0 v 18.1 months), 2-year survival (31% v 40%), or local/regional failure and local/regional persistence of disease (56% v 52%) between the high-dose and standard-dose arms. Although 11 treatment-related deaths occurred in the high-dose arm compared with two in the standard-dose arm, seven of the 11 deaths occurred in patients who had received 50.4 Gy or less. Conclusion: The higher radiation dose did not increase survival or local/regional control. Although there was a higher treatment-related mortality rate in the patients assigned to the high-dose radiation arm, it did not seem to be related to the higher radiation dose. The standard radiation dose for patients treated with concurrent 5-FU and cisplatin chemotherapy is 50.4 Gy.

Original languageEnglish (US)
Pages (from-to)1167-1174
Number of pages8
JournalJournal of Clinical Oncology
Volume20
Issue number5
DOIs
StatePublished - Mar 1 2002

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Combined Modality Therapy
Radiation Oncology
Esophageal Neoplasms
Radiotherapy
Fluorouracil
Radiation
Survival
Cisplatin
iodonitrotetrazolium
Radiation Dosage
Drug Therapy
Weight Loss
Squamous Cell Carcinoma
Histology
Appointments and Schedules
Adenocarcinoma
Therapeutics
Mortality

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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INT 0123 (Radiation therapy oncology group 94-05) phase III trial of combined-modality therapy for esophageal cancer : High-dose versus standard-dose radiation therapy. / Minsky, Bruce D.; Pajak, Thomas F.; Ginsberg, Robert J.; Pisansky, Thomas M.; Martenson, James; Komaki, Ritsuko; Okawara, Gordon; Rosenthal, Seth A.; Kelsen, David P.

In: Journal of Clinical Oncology, Vol. 20, No. 5, 01.03.2002, p. 1167-1174.

Research output: Contribution to journalArticle

Minsky, BD, Pajak, TF, Ginsberg, RJ, Pisansky, TM, Martenson, J, Komaki, R, Okawara, G, Rosenthal, SA & Kelsen, DP 2002, 'INT 0123 (Radiation therapy oncology group 94-05) phase III trial of combined-modality therapy for esophageal cancer: High-dose versus standard-dose radiation therapy', Journal of Clinical Oncology, vol. 20, no. 5, pp. 1167-1174. https://doi.org/10.1200/JCO.20.5.1167
Minsky, Bruce D. ; Pajak, Thomas F. ; Ginsberg, Robert J. ; Pisansky, Thomas M. ; Martenson, James ; Komaki, Ritsuko ; Okawara, Gordon ; Rosenthal, Seth A. ; Kelsen, David P. / INT 0123 (Radiation therapy oncology group 94-05) phase III trial of combined-modality therapy for esophageal cancer : High-dose versus standard-dose radiation therapy. In: Journal of Clinical Oncology. 2002 ; Vol. 20, No. 5. pp. 1167-1174.
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title = "INT 0123 (Radiation therapy oncology group 94-05) phase III trial of combined-modality therapy for esophageal cancer: High-dose versus standard-dose radiation therapy",
abstract = "Purpose: To compare the local/regional control, survival, and toxicity of combined-modality therapy using high-dose (64.8 Gy) versus standard-dose (50.4 Gy) radiation therapy for the treatment of patients with esophageal cancer. Patients and Methods: A total of 236 patients with clinical stage T1 to T4, N0/1, M0 squamous cell carcinoma or adenocarcinoma selected for a nonsurgical approach, after stratification by weight loss, primary tumor size, and histology, were randomized to receive combined-modality therapy consisting of four monthly cycles of fluorouracil (5-FU) (1,000 mg/m2/24 hours for 4 days) and cisplatin (75 mg/m2 bolus day 1) with concurrent 64.8 Gy versus the same chemotherapy schedule but with concurrent 50.4 Gy. The trial was stopped after an interim analysis. The median follow-up was 16.4 months for all patients and 29.5 months for patients still alive. Results: For the 218 eligible patients, there was no significant difference in median survival (13.0 v 18.1 months), 2-year survival (31{\%} v 40{\%}), or local/regional failure and local/regional persistence of disease (56{\%} v 52{\%}) between the high-dose and standard-dose arms. Although 11 treatment-related deaths occurred in the high-dose arm compared with two in the standard-dose arm, seven of the 11 deaths occurred in patients who had received 50.4 Gy or less. Conclusion: The higher radiation dose did not increase survival or local/regional control. Although there was a higher treatment-related mortality rate in the patients assigned to the high-dose radiation arm, it did not seem to be related to the higher radiation dose. The standard radiation dose for patients treated with concurrent 5-FU and cisplatin chemotherapy is 50.4 Gy.",
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T1 - INT 0123 (Radiation therapy oncology group 94-05) phase III trial of combined-modality therapy for esophageal cancer

T2 - High-dose versus standard-dose radiation therapy

AU - Minsky, Bruce D.

AU - Pajak, Thomas F.

AU - Ginsberg, Robert J.

AU - Pisansky, Thomas M.

AU - Martenson, James

AU - Komaki, Ritsuko

AU - Okawara, Gordon

AU - Rosenthal, Seth A.

AU - Kelsen, David P.

PY - 2002/3/1

Y1 - 2002/3/1

N2 - Purpose: To compare the local/regional control, survival, and toxicity of combined-modality therapy using high-dose (64.8 Gy) versus standard-dose (50.4 Gy) radiation therapy for the treatment of patients with esophageal cancer. Patients and Methods: A total of 236 patients with clinical stage T1 to T4, N0/1, M0 squamous cell carcinoma or adenocarcinoma selected for a nonsurgical approach, after stratification by weight loss, primary tumor size, and histology, were randomized to receive combined-modality therapy consisting of four monthly cycles of fluorouracil (5-FU) (1,000 mg/m2/24 hours for 4 days) and cisplatin (75 mg/m2 bolus day 1) with concurrent 64.8 Gy versus the same chemotherapy schedule but with concurrent 50.4 Gy. The trial was stopped after an interim analysis. The median follow-up was 16.4 months for all patients and 29.5 months for patients still alive. Results: For the 218 eligible patients, there was no significant difference in median survival (13.0 v 18.1 months), 2-year survival (31% v 40%), or local/regional failure and local/regional persistence of disease (56% v 52%) between the high-dose and standard-dose arms. Although 11 treatment-related deaths occurred in the high-dose arm compared with two in the standard-dose arm, seven of the 11 deaths occurred in patients who had received 50.4 Gy or less. Conclusion: The higher radiation dose did not increase survival or local/regional control. Although there was a higher treatment-related mortality rate in the patients assigned to the high-dose radiation arm, it did not seem to be related to the higher radiation dose. The standard radiation dose for patients treated with concurrent 5-FU and cisplatin chemotherapy is 50.4 Gy.

AB - Purpose: To compare the local/regional control, survival, and toxicity of combined-modality therapy using high-dose (64.8 Gy) versus standard-dose (50.4 Gy) radiation therapy for the treatment of patients with esophageal cancer. Patients and Methods: A total of 236 patients with clinical stage T1 to T4, N0/1, M0 squamous cell carcinoma or adenocarcinoma selected for a nonsurgical approach, after stratification by weight loss, primary tumor size, and histology, were randomized to receive combined-modality therapy consisting of four monthly cycles of fluorouracil (5-FU) (1,000 mg/m2/24 hours for 4 days) and cisplatin (75 mg/m2 bolus day 1) with concurrent 64.8 Gy versus the same chemotherapy schedule but with concurrent 50.4 Gy. The trial was stopped after an interim analysis. The median follow-up was 16.4 months for all patients and 29.5 months for patients still alive. Results: For the 218 eligible patients, there was no significant difference in median survival (13.0 v 18.1 months), 2-year survival (31% v 40%), or local/regional failure and local/regional persistence of disease (56% v 52%) between the high-dose and standard-dose arms. Although 11 treatment-related deaths occurred in the high-dose arm compared with two in the standard-dose arm, seven of the 11 deaths occurred in patients who had received 50.4 Gy or less. Conclusion: The higher radiation dose did not increase survival or local/regional control. Although there was a higher treatment-related mortality rate in the patients assigned to the high-dose radiation arm, it did not seem to be related to the higher radiation dose. The standard radiation dose for patients treated with concurrent 5-FU and cisplatin chemotherapy is 50.4 Gy.

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