Zachariah 2010

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

Zachariah 2010

Jornal of the National Cancer Institute

Monocenter, randomized, double-binded, placebo-controlled study

Two arms

N=215

USA

12/2003-02/2006

Anorectal cancer patients

27-85 yrs.

m/f

45 Gy, 1.5-2 Gy daily

N= 109

4-7 days before the start of RTX 30 mg dose long-acting octreotide acetate (LAO) i.m. and on day 22 ±3 days of RTX

N= 106

4-7 days before the start of RTX 30 mg dose placebo i.m. and on day 22 ±3 days of RTX

Primary Endpoint. Incidence of grade 2-4 acute diarrhea

Secondary Endpoints: treatment compliance, medical resource utilization, patient-reported bowel function and quality of life (QoL)

Diarrhea

Grade 2-4 (48/109 vs. 52/106)

Grade 3-4 (25/109 vs. 29/106)

No statistically significant difference in patient-reported bowel function or QoL

No statistically significant difference in study drug compliance

Grants to the Radiation therapy Oncology Group (RTOG) from the National Cancer Institute and Novartis

1b/1+

“…the prophylactic use of LAO did not prevent the incidence or reduce the severity of diarrhea and had no notable impact on patient-reported bowel function or QoL.”