Phase III Study on the Administration Method of Adjuvant UFT and Leucovorin Calcium in Patients with Resected Colorectal Cancer (Thrice-Daily versus Twice-Daily Regimen)

2020 ◽  
Author(s):  
Taishi Hata ◽  
Masakazu Miyake ◽  
Kiyotaka Hagihara ◽  
Anna Tsutsui ◽  
Hiroki Akamatsu ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase Iii ◽  
Daily Regimen ◽  
Phase Iii Study ◽  
Administration Method ◽  
Leucovorin Calcium

scholarly journals Administration Method of Adjuvant Tegafur‐Uracil and Leucovorin Calcium in Patients with Resected Colorectal Cancer: A Phase III Study

2021 ◽  
Author(s):  
Taishi Hata ◽  
Kiyotaka Hagihara ◽  
Anna Tsutsui ◽  
Hiroki Akamatsu ◽  
Masayuki Ohue ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase Iii ◽  
Phase Iii Study ◽  
Administration Method ◽  
Leucovorin Calcium

scholarly journals Quality-of-life findings from a randomised phase-III study of XELOX vs FOLFOX-6 in metastatic colorectal cancer

2009 ◽  
Vol 102 (1) ◽  
pp. 59-67 ◽  
Author(s):  
T Conroy ◽  
M Hebbar ◽  
J Bennouna ◽  
M Ducreux ◽  
M Ychou ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Iii ◽  
Phase Iii Study

Fluorouracil plus racemic leucovorin versus fluorouracil combined with the pure l-isomer of leucovorin for the treatment of advanced colorectal cancer: a randomized phase III study.

1997 ◽  
Vol 15 (3) ◽  
pp. 908-914 ◽  
Author(s):  
W Scheithauer ◽  
G Kornek ◽  
A Marczell ◽  
G Salem ◽  
J Karner ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Gastrointestinal Symptoms ◽  
Dose Schedule ◽  
Phase Iii ◽  
Biochemical Modulation ◽  
Survival Times ◽  
Significant Difference ◽  
Duration Of Response ◽  
Phase Iii Study

PURPOSE To compare the efficacy and toxicity of fluorouracil (FU) and racemic leucovorin (d,l-LV) versus FU combined with the l-isomer of leucovorin (l-LV) in the treatment of advanced colorectal cancer. PATIENTS AND METHODS A total of 248 patients with advanced measurable colorectal cancer previously unexposed to chemotherapy were randomly assigned to treatment with either FU (400 mg/m2/d by intravenous [I.V.] infusion for 2 hours) and racemic LV (100 mg/m2/d by I.V. bolus injection) given for 5 consecutive days, or the combination of FU and the pure l-isomer of LV using the same dose schedule. In both treatment arms, courses were administered every 28 days if toxicity allowed for a total of 6 months, unless evidence of tumor progression was documented earlier. RESULTS There were no significant differences between the FU/racemic LV and the FU/l-LV arm in the overall response rate (25% v 32%), duration of response (7.2 v 8.0 months), median time to progression or death (6.25 v 8.0 months), or median overall survival time (14.5 v 15.0 months). Except for minor myeloid toxic effects associated with FU/l-LV, there was also no significant difference in terms of adverse reactions. Gastrointestinal symptoms, specifically mucasitis and diarrhea, were less frequent and less severe in both treatment arms compared with other trials with FU/racemic LV reported in the literature, which might be because of the prolonged administration of FU used in both arms. CONCLUSION The combination of FU/l-LV produced response rates, response durations, and survival times similar to those with FU/d,l-LV. Biochemical modulation of FU by either pure l-LV or racemic LV thus appears to result in equivalent clinical efficacy.

scholarly journals LUME-Colon 1: a randomized phase III study of nintedanib vs placebo in patients with advanced colorectal cancer

2015 ◽  
Vol 26 ◽  
pp. vii130
Author(s):  
Takayuki Yoshino ◽  
Josep Tabernero ◽  
Zohra Oum'Hamed ◽  
Matus Studeny ◽  
Mouna Sassi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Phase Iii ◽  
Phase Iii Study

Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) As First-Line Treatment for Metastatic Colorectal Cancer: The Gruppo Oncologico Nord Ovest

2007 ◽  
Vol 25 (13) ◽  
pp. 1670-1676 ◽  
Author(s):  
Alfredo Falcone ◽  
Sergio Ricci ◽  
Isa Brunetti ◽  
Elisabetta Pfanner ◽  
Giacomo Allegrini ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Peripheral Neurotoxicity ◽  
Phase Iii Trial ◽  
Free Survival ◽  
Secondary Resection ◽  
Phase Iii Study ◽  
Grade 3

Purpose The Gruppo Oncologico Nord Ovest (GONO) conducted a phase III study comparing fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI [irinotecan 165 mg/m2 day 1, oxaliplatin 85 mg/m2 day 1, leucovorin 200 mg/m2 day 1, fluorouracil 3,200 mg/m2 48-hour continuous infusion starting on day 1, every 2 weeks]) with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI). Methods Selection criteria included unresectable metastatic colorectal cancer, age 18 to 75 years, and no prior chemotherapy for advanced disease. The primary end point was response rate (RR). Results A total of 244 patients were randomly assigned. An increase of grade 2 to 3 peripheral neurotoxicity (0% v 19%; P < .001), and grade 3 to 4 neutropenia (28% v 50%; P < .001) were observed in the FOLFOXIRI arm. The incidence of febrile neutropenia (3% v 5%) and grade 3 to 4 diarrhea (12% v 20%) were not significantly different. Responses, as assessed by investigators, were, for FOLFIRI and FOLFOXIRI, respectively, complete, 6% and 8%; and partial, 35% and 58%, (RR, 41% v 66%; P = .0002). RR confirmed by an external panel was 34% versus 60% (P < .0001). The R0 secondary resection rate of metastases was greater in the FOLFOXIRI arm (6% v 15%; P = .033, among all 244 patients; and 12% v 36%; P = .017 among patients with liver metastases only). Progression-free survival (PFS) and overall survival (OS) were both significantly improved in the FOLFOXIRI arm (median PFS, 6.9 v 9.8 months; hazard ratio [HR], 0.63; P = .0006; median OS, 16.7 v 22.6 months; HR, 0.70; P = .032). Conclusion The FOLFOXIRI regimen improves RR, PFS, and OS compared with FOLFIRI, with an increased, but manageable, toxicity in patients with metastatic colorectal cancer with favorable prognostic characteristics. Further studies of FOLFOXIRI in combination with targeted agents and in the neoadjuvant setting are warranted.

scholarly journals Analysis of KRAS/NRAS Mutations in a Phase III Study of Panitumumab with FOLFIRI Compared with FOLFIRI Alone as Second-line Treatment for Metastatic Colorectal Cancer

2015 ◽  
Vol 21 (24) ◽  
pp. 5469-5479 ◽  
Author(s):  
Marc Peeters ◽  
Kelly S. Oliner ◽  
Timothy J. Price ◽  
Andrés Cervantes ◽  
Alberto F. Sobrero ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Iii ◽  
Line Treatment ◽  
Second Line ◽  
Phase Iii Study
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