S-1 Combined With IMRT Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Summary

This study is a prospective phase II trial which is designed to evaluate the efficacy and safety of IMRT combined with S-1 CCRT for locally advanced NPC. Eligibility criteria include histologically confirmed locally advanced NPC according to the American Joint Committee on Cancer (AJCC) Staging System (the eighth edition); Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; at least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1; normal complete blood count, normal hepatic function and normal renal function. Prior induction chemotherapy with platinum was allowed. Exclusion criteria include previous radiotherapy, a history of any other type of malignancy; pregnancy or lactation; allergy to S-1; obvious dysfunction of liver, renal, cardiac or lung function; uncontrolled infection; systemic metastasis or distant metastasis; patients with severe gastrointestinal diseases, and patients with mental disorders affecting patient participation in trial judgement. The full-set pretreatment evaluation will be performed to every patient.All patients in this study will receive intensity-modulated radiation therapy (IMRT). During the IMRT course, S-1 will be administered orally according to body surface area.The dose modifications of S-1 will not be permitted during concurrent chemotherapy unless progression of the disease, toxicities of grade 4 or patient's refusal. The primary endpoints of this study is adverse events (AE) rate and progression-free survival (PFS).

Timeline

Start

2013-08-01

Primary completion

2018-12-01

Completion

2020-08-01

Drugs

Indications