KURZPROTOKOLL S-TRAC Öffentlicher Titel Sunitinib als adjuvante Therapie bei Nierenzellkarzinom Wissenschaftl. Titel Sunitinib treatment of renal adjuvant cancer (S-TRAC): a randomized double-blinded phase 3 study of adjuvant Sunitinib vs. Placebo in subjects at high risk of recurrent RCC Kurztitel S-TRAC Studienart multizentrisch, prospektiv, randomisiert, Pharma-Studie, doppelblind, zweiarmig Studienphase Phase III Erkrankung URO: Nierenzellkarzinom: Adjuvant Ziele - Disease-free survival comparing sunitinib with placebo [ Time Frame: 24 months ] - Overall Survival [ Time Frame: 5 years ] - Safety [ Time Frame: 12 months ] - Tolerability [ Time Frame: 12 months ] - Patient-reported outcomes [ Time Frame: 12 months ] - High risk renal cancer per modified UISS criteria - ECOG 0-2 - predominant clear cell histology - No prior anti-cancer treatment - Kidney tumor has been removed - No evidence of macroscopic disease following surgery - Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites. - Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months - known HIV or Hepatitis - any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration Einschlusskriterien Ausschlusskriterien Alter 18 Jahre und älter Status Nachbeobachtung Beginn der Rekrutierung 01.07.2007 Fallzahl 236 Förderer Pfizer Registrierung in anderen Studienregistern ClinicalTrials NCT00375674 (primäres Register) EUDRACT 2006-004024-37 Therapie Arm A (Experimental):Sunitinib malate sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent. Arm B (Placebo Comparator): Placebo Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 18.08.2016; Seite 1 von 1
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