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We present the treatment rationale and study design of GOIRC trial (FARM6PMFJM study), a multicenter randomized phase III study, supported by AIFA (Agenzia Italiana del Farmaco).
This multicenter randomized phase III study was designed to compare the efficacy and toxicity of IFNα-2c (3.5 MU/d) in combination with either araC (10 mg/m2 d1-10) or hydroxyurea (HU: 25 mg/kg per day) in newly diagnosed CML patients.
EXPERIMENTAL DESIGN: For our study population, we used the TAX327 multicenter randomized phase III trial comparing administration of docetaxel and prednisone every 3 weeks, weekly administration of docetaxel and prednisone, and administration of mitoxantrone and prednisone every 3 weeks.
Recent results from a multicenter, randomized phase III trial, the UK ABC-02 trial that evaluated GEM with or without cisplatin in patients with advanced or metastatic BTC have demonstrated a clear survival advantage (hazard ratio 0.68, P = 0.002) for the combination of GEM and cisplatin (GC regimen) without added clinically intolerable toxicity [5].
CHARISMA is a multicenter, randomized, phase III clinical trial.
IMRT-MC2 is a prospective, two-armed, multicenter, randomized, phase III trial.
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Rimonabant is now undergoing a multicenter randomized, double-blind phase III trial in order to assess the effects on weight loss in obese patients with or without comorbidities, with dislipidemia and with type II diabetes (http://www.clinicaltrials.gov).gov
The IMRT-MC2 study is a prospective, two armed, multicenter, randomized phase-III-trial comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy with consecutive boost in patients with breast cancer after breast conserving surgery.
A 4-arm multicenter, randomized cooperative phase III study for advanced non small-cell lunon small-cellurrentlungnderway.
Prof. Jun Ma reported the preliminary results of a multicenter randomized controlled phase III trial comparing concurrent chemoradiotherapy with or without adjuvant chemotherapy [16].
One abstract (level 3 evidence) which detailed results from a pooled analysis of two multicenter randomized controlled phase II trials in patients with type 1 and type 2 diabetes was also excluded due to the availability of significant level 2 evidence (Cappelleri et al. 2001).
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