ICCG FEMTX Trial
Adjuvant phase III randomised study of high dose methotrexate and 5-Fluorouracil combined with epirubicin (FEMTX) versus control in patients with resected gastric cancer.
Disease site: Stomach cancer Other cancers
Treatment modality: Surgery
Status: Closed
Trial details
The aim of this study was to investigate in patients who underwent radical resection for gastric cancer the relative efficacy of 5-Fluorouracil combined with epirubicin vs control. This trial was open to patients of up to 71 years old; with histologically proven adenocarcinoma of the stomach or distal oesophagus (oesophago-gastric junction with cardias involvement) for which curative surgery was performed, and disease stage T2, T3, T4, or T1 with histologically confirmed lymph node involvement (i.e. stage II & III).
191 patients were randomised from 16 ICCG centres.
This study has been analysed in collaboration with the EORTC study of FAMTX vs Control (206 patients from 23 EORTC centres).
No significant differences in disease-free or overall survival were seen between the FEMTX/FAMTX and control arms.
This is an International Collaborative Cancer Group (ICCG) trial (C/7/89).
Publication and presentations
Nitti D, Wils J, Dos Santos JG, Fountzilas G, Conte PF, Sava C, Tres A, Coombes RC, Crivellari D, Marchet A, Sanchez E, Bliss JM, Homewood J, Couvreur ML, Hall E, Baron B, Woods E, Emson M, Van Cutsem E, Lise M. Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG. Ann. Oncol. 2006;17:262-69
Wils J, Nitti D, Guimaraes-Dos Santos J, Fountzilas G, Conte F, Sava C, Tres A, Sanchez E, Homewood J, Courveur ML, Hall E, Baron B, Lise M. Randomized phase III studies of adjuvant chemotherapy with FAMTX or FEMTX in resected gastric cancer. Pooled results of studies from the EORTC GI group and the ICCG. J. Clin. Oncol. 2002;21:131A #521
Nitti D, Wils J, Conte PF, Fountzilas G, Lise M, Bliss J, Sahmoud T, Marinus A, Woods E, for the I, the EGIg. Toxicity analysis of adjuvant FEMTX or FAMTX for resected gastric cancer. Second International Conference on Biology, Prevention and Treatment of Gastrointestinal Malignancies; 1995; Koln, Germany.
Wils J, Bliss JM, Coombes R, Amadori D, Fountzilas G, Klein H, Pinto-Ferreira E, Reis H, Vassilopoulos P, Woods E, for the International Collaborative Cancer G. Phase I-II study of sequential high dose methotrexate (MTX) and 5-fluorouracil (F) combined with epirubicin (E) (FEMTX) in advanced gastric cancer. Proceeds of the European Society of Medical Oncology; 1995.
Wils JA, Coombes RC, Bliss JM, Law M, Fountzilas G, Amadori D, Abad-Esteve A, Klein HO, Pinto-Ferreira E, Reis H, Vassilopoulos P, Tres A, Woods E. Phase I-II study of sequential high dose methotrexate and 5-fluorouracil combined with epirubicin (FEMTX) at different dose levels in advanced gastric cancer. GI Reports 1995;1:55-59
Wils JA, Wagener D, Coombes RC, Fountzilas G, Bliss JM, Law M, Woods E, Smith L, for the International Collaborative Cancer G. Phase III trial of fluorouracil, methotrexate and epirubicin (FEMTX) versus FEMTX plus cisplatin (FEMTX-P) in advanced gastric cancer. Second International Conference on Biology, Prevention and Treatment of Gastrointestinal Malignancies; 1995; Koln, Germany.
Wils J, Coombes RC, Bliss J, Law M, Fountzilas G, Reis H, Vassilopoulos P, Klein HO, Pinto-Ferreira E, Tres A, Amadori D, Abad A, Woods E, for the International Collaborative Cancer G. Phase I-II study of sequential high dose methotrexate MTX and 5FU combined with epirubicin (FEMTX) in advanced gastric cancer. EORTC Symposium on Research, Diagnosis and Ttreatment of Gastrointestinal Cancer; 1993; Porto.
Wils J, Bliss JM, Coombes R, Amadori D, Fountzilas G, Klein HO, Pinto-Ferreira E, Reis H, Vassilopoulos P, Woods E. Phase I-II study of sequential high-dose methotrexate (mtx) and 5-fluorouracil (f) combined with epirubicin (e) [femtx] in advanced gastric cancer (meeting abstract). Ann. Oncol. 1990;1(Suppl 1):43 #P6:3