Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2002-03-01
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/m(2)/24 hours for 4 days) and cisplatin (75 mg/m(2) 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.
Related Questions
Let's re-open the debate!
New comment by Radiation Oncologist at University of Texas MD Anderson Cancer Center ( July 16, 2019)
@Michael Buckstein well summarizes the data (or lack thereof)
Philosophically, as someone who treats almost exclusively head and neck cancer, I have used the same princi...
Would your approach change if the histology were adenocarcinoma?
New answer by Radiation Oncologist at Varian Medical Systems/Allegheny health network (February 5, 2016)
We normally plan for 50.4 Gy to 59.4 Gy based on tolerance, realizing the fact that RTOG didn't show a benefit for more than 50.4 Gy. The European studies which compared tripl...
If the patient has large, bulky nodes would you consider starting after chemotherapy for cytoreduction? Or otherwise consider replanning mid-treatment...
New answer by Radiation Oncologist at Mount Sinai Medical Center (April 18, 2018)
I agree with the answer posted above. For the sake of fairness, the referenced Stahl trial did use induction chemotherapy (a very complicated regimen), but the FFCD did not. B...
If a patient is unable or unwillling to undergo dual or tri-modality therapy with chemotherapy or surgery, would you use a palliative radiation treatm...
New answer by Radiation Oncologist at Fox Chase Cancer Center (May 20, 2018)
This is a question that comes up occasionally in clinic. My viewpoint is generally based on the prospective data that we have. Of course, the RTOG 85-01 study showed 0% long-t...
New answer by Radiation Oncologist at Lake Huron Medical Center (April 30, 2021)
The 5Y survival of RTOG 8501’s RT alone arm was 0%. They used 64/32 Gy. So... I tend to think that RT alone is purely palliative and generally stick with 40/15 to provid...