Comparison of concurrent chemoradiation therapy with 3-weekly versus weekly cisplatin in patients with locally advanced nasopharyngeal cancer: A multicenter randomized phase II noninferiority trial (KCSG-HN10-02).

6023 Background: Concurrent chemoradiation therapy (CCRT) with every 3 week schedule of cisplatin is the standard treatment for locally advanced nasopharyngeal carcinoma (NPC), but concerns have been raised about treatment-related complications. We conducted a randomized phase II non-inferiority study of CCRT with three week versus weekly cisplatin to compare the efficacy and toxicity profiles. Methods: From September 2009 through August 2011, 111 patients with locally advanced NPC who have stage II-IVb were enrolled from 22 centers in Korea. Patients were randomized into treatment groups that either received cisplatin 100 mg/m² every 3 weeks for 3 cycles (arm A) or cisplatin 40 mg/m² weekly for 7 cycles (arm B) concurrently with RT. Subsequent adjuvant chemotherapy, cisplatin 80 mg/m² day 1 and fluorouracil 1,000 mg/m²/day day 1-4 was administered every 3 weeks for a total of 3 cycles. Results: Of the 109 eligible patients, 56 were assigned to arm A, and 53 to arm B. The two arms were well-balanced in al...