S-1 Combined With IMRT Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Status:
Completed
Trial end date:
2020-08-01
Target enrollment:
Participant gender:
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).