Zhang 2012

Supportive Therapie · Version 2.1

Referenz

(Autor, Jahr, Journal)

Studientyp

Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum

Patientenmerkmale

Indikation, Alter, Geschlecht (m/w), CTX

Intervention

Kontrolle

Zielgröße

Primary Endpoint

Secondary Endpoint

Finanzierung

Evidenzstufe (CEBM levels/ SIGN)

Bei Abwertung: Angabe von Gründen

Zhang

2012

Ann Oncol

Single-center, prospective randomized clinical trial

N= 150

China

stage II and III colorectal cancer

≥18 years

(median age of patients in study was 56.96 years)

Regimen: oxaliplatin 130 mg/m2 day 1, oral capecitabine 1000 mg/m2 2x daily or capecitabine monotherapy 1250 mg/m2 2x daily

N= 68

Capecitabine/celecoxib group (18 patients in capecitabine/celecoxib group and 50 patients in capecitabine/oxaliplatine/celecoxib group)

N=71

Capecitabine group (19 patients in capecitabine alone group and 52 patients in the capecitabine/oxaliplatine group)

Primary Endpoint:

Explore the ability of celecoxib to prevent HFS induced by capecitabine

Incidence of ≥ grade 1 and ≥ grade 2 HFS:

Capecitabine group and capecitabine/celecoxib (74.6% versus 57.4%, P = 0.034, 29.6% versus 14.7% P = 0.035).

Grade 3 HFS (8.5% versus 2.9% P = 0.303)

 

Research Funding: None

 

1b

No placebo-controlled trial