Preoperative radiotherapy as adjuvant treatment in rectal cancer. Final results of a randomized study of the European Organization for Research and Treatment of Cancer (EORTC).
A randomized clinical trial was conducted by the European Organization for Research and Treatment for Cancer (EORTC) Gastrointestinal Cancer Cooperative Group to study the effectiveness of irradiation therapy administered in a dosage of 34.5 Gy, divided into 15 daily doses of 2.3 Gy each before radical surgery for rectal cancer (T2, T3, T4, NX, MO). Four hundred sixty-six patients were entered in the clinical trial between June 1976 and September 1981. Tolerance and side effects of preoperative irradiation were acceptable. The overall 5-year survival rates were similar in both groups. When considering only the 341 patients treated by surgery with a curative aim, the 5-year survival rates were 59.1% and 69.1% in the control group and in the combined modality group, respectively (p = 0.08). The local recurrence rates at 5 years were 30% and 15% in the control group and the adjuvant radiotherapy group, respectively (p = 0.003). Although this study did not show preoperative radiotherapy to have a statistically significant benefit on overall survival, it does have a clear effect on local control of rectal cancer. Therefore, before performing radical surgery, this adjuvant therapy should be administered to patients who have locally extended rectal cancer.
Gérard
A
A
Institut Jules Bordet, Department of Surgery, Brussels, Belgium.
Buyse
M
M
Nordlinger
B
B
Loygue
J
J
Pène
F
F
Kempf
P
P
Bosset
J F
JF
Gignoux
M
M
Arnaud
J P
JP
Desaive
C
C
D000230:Adenocarcinoma / Q000453:epidemiology / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D011300:Preoperative Care / Q000379:methods*; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D011897:Random Allocation; D012004:Rectal Neoplasms / Q000453:epidemiology / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D013997:Time Factors