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

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fudan University

Criteria

Inclusion Criteria:

• Histologically confirmed locally advanced NPC

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

• Normal complete blood count

• Normal hepatic function

• Normal renal function (creatinine ≤ 1.5 times the upper limit of normal).

Exclusion Criteria:

• Previous radiotherapy

• A history of any other type of malignancy

• Pregnancy or lactation

• Allergy to S-1

• Obvious disfunction of liver, renal, cardiac or lung function

• Uncontrolled infection

• Systemic metastasis or distant metastasis

• Patients with severe gastrointestinal diseases

• Patients with mental disorders affecting patient participation in trial judgement.