drugset / Trial / NCT01500993
Capecitabine in the Perioperative Treatment of Rectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study compares capecitabine with standard 5-FU in the perioperative treatment of locally advanced rectal cancer.
Timeline
- Start
- 2002-03
- Primary completion
- 2011-03
- Completion
- 2011-03
Outcome
Met primary endpoint
paper 5-year overall survival in the capecitabine group was non-inferior to that in the fluorouracil group PMID 22503032 ↗
Publications
- Results Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Muller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. doi: 10.1016/S1470-2045(12)70116-X. Epub 2012 Apr 13.
- Garcia-Albeniz X, Gallego R, Hofheinz RD, Fernandez-Esparrach G, Ayuso-Colella JR, Bombi JA, Conill C, Cuatrecasas M, Delgado S, Gines A, Miquel R, Pages M, Pineda E, Pereira V, Sosa A, Reig O, Victoria I, Feliz L, Maria de Lacy A, Castells A, Burkholder I, Hochhaus A, Maurel J. Adjuvant therapy sparing in rectal cancer achieving complete response after chemoradiation. World J Gastroenterol. 2014 Nov 14;20(42):15820-9. doi: 10.3748/wjg.v20.i42.15820.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1650 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 2500 mg/m2 | Oral |
| Comparator | fluorouracil | Small molecule | 225 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 500 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 1000 mg/m2 | — |