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 Article
| Authors: | Minsky, B. D.; Pajak, T. F.; Ginsberg, R. J.; Pisansky, T. M.; Martenson, J.; Komaki, R.; Okawara, G.; Rosenthal, S. A.; Kelsen, D. P. |
| Article 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. © 2002 by American Society of Clinical Oncology. |
| Keywords: | adult; cancer survival; controlled study; treatment outcome; aged; aged, 80 and over; middle aged; treatment failure; major clinical study; clinical trial; histopathology; squamous cell carcinoma; carcinoma, squamous cell; cisplatin; fluorouracil; cancer combination chemotherapy; multimodality cancer therapy; cancer radiotherapy; radiation dose; combined modality therapy; follow up; adenocarcinoma; controlled clinical trial; neoplasm recurrence, local; randomized controlled trial; radiotherapy dosage; radiotherapy; weight reduction; radiation injury; cancer mortality; radiation response; survival time; cancer size; phase 3 clinical trial; cancer control; esophagus carcinoma; esophageal neoplasms; drug induced disease; humans; human; male; female; priority journal; article |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 20 |
| Issue: | 5 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2002-03-01 |
| Start Page: | 1167 |
| End Page: | 1174 |
| Language: | English |
| DOI: | 10.1200/jco.20.5.1167 |
| PUBMED: | 11870157 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Export Date: 14 November 2014 -- Source: Scopus |
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