Katsanos_2010
Supportive Therapie · Version 2.1
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Referenz (Autor, Jahr, Journal) |
Studientyp Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum
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Patienten-merkmale Indikation, Alter, Geschlecht (m/w) |
Intervention Fallzahl n, Beschreibung der präventiven bzw. therapeutischen Maßnahme |
Kontrolle Fallzahl n, Beschreibung der präventiven Maßnahme bzw. therapeutischen Maßnahme |
Zielgrößen Primärer Endpunkt Sekundäre(r) Endpunkt(e) |
Primärer Endpunkt Angaben für Intervention vs. Kontrolle |
Sekundäre(r) Endpunkt(e) Angaben für Intervention vs. Kontrolle |
Finanzierung |
Evidenzstufe Bei Abwertung: Angabe von Gründen Bewertung des Autors |
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Katsanos
2010
Journal of Experimental & Clinical Cancer Research |
randomised phase II exploratory clinical trial
n = 44
Greece
activated in May 2001 |
cancer patients receiving radical radiotherapy to the pelvis
N = 44 pts
Female: 23 males: 21
median age: 63 years (range 35-79 years)
Tumor types: Rectal: 20 Cervical: 12 Prostat:e 5 Bladder: 3 Endometrial: 2 Sarcoma: 2 |
n = 21 amifostine (subcutaneously, 500 mg flat dose) before radiotherapy (A)
Amifostine injection was repeated daily(5 days/week), 20-30 minutes before radiotherapy |
n = 23
radiotherapy alone (R) |
primary endpoint: efficacy of amifostine in preventing radiation-induced colitis (RC)
secondary endpoint: assessment of agreement between clinical, endoscopic and histopathologic data during radiotherapy and post-radiotherapy period, evaluation of amifostine-related toxicity
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A + R vs. R
acute radiation colitis 0 (0%) vs. 4 (17,4%) p = 0.05
late radiation colitis 7 (28,6%) vs. 8 (34,8%) |
119 sigmoidoscopies 18 pts (18/44, 40.9%) diagnosed with radiation colitis (15 grade 1 and 2, and 3 grade 3 and 4)
Group A+R vs. R 6/21, 28.6% vs. 12/23, 52.2%
4 pts (17.4%) in the R group: acute and grade IV radiation
Amifostine side effects were mild. |
The authors declare that they have no competing interests |
2b small sample size
"Amifostine given subcutaneously can lower the risk of acute severe radiation colitis in patients who receive radical radiotherapy to pelvic tumors." |