Premium
Interim analysis of a phase III study on preoperative radiation therapy in resectable rectal carcinoma. Trial of the gastrointestinal tract cancer cooperative group of the European organization for research on treatment of cancer (EORTC)
Author(s) -
Gerard André,
Berrod JeanLouis,
Pene Françoise,
Loygue Jean,
Laugier Alain,
Bruckner Robert,
Camelot Gabriel,
Arnaud JeanPierre,
Metzger Urs,
Buyse Marc,
Dalesio Otilia,
Duez Nicole
Publication year - 1985
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19850515)55:10<2373::aid-cncr2820551012>3.0.co;2-d
Subject(s) - medicine , radiation therapy , surgery , interim analysis , randomized controlled trial , radical surgery , colorectal cancer , cancer , clinical trial , adjuvant , carcinoma
To improve surgical results of potentially operable rectal cancer (T2, T3, T4, Mo), the European Organization for Research on Treatment of Cancer (EORTC) conducted a two‐arm randomized clinical trial to evaluate the effect of administering radiotherapy before radical surgery. Four hundred ten patients were allocated to be treated either by surgery alone or by 34.5 Gy of radiotherapy (in 19 days overall) followed by surgery. The tolerance of the adjuvant radiation therapy was fairly good. The 5‐year survival rate was 65% overall and showed no difference between both therapeutic regimens. Similarly, the metastases‐free rate was the same in both groups. In contrast, the preoperative radiation therapy showed a marked effect on local control of the disease, the comparison of the time to local recurrence being highly significant between the two treatment groups ( P = 0.001). The proportion of patients free of local recurrence at 5 years was 85% in the combined treatment versus 65% in the group of patients treated by surgery alone.