Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and safety of sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of sequential chemoradiotherapy in NPC patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chaosu Hu
• Collaborators: Affiliated Hospital of Jiangnan University; First Affiliated Hospital of Wenzhou Medical University; Fujian Cancer Hospital; Jiangxi Provincial Cancer Hospital; Zhejiang Cancer Hospital
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type)

• Tumor staged as III-IVA (according to the 8th AJCC edition).

• Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.

• Age between 18 and 60 years old.

• Adequate marrow: Neutrophil count ≥2000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.

• Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.

• Adequate renal function: creatinine clearance ≥60 ml/min.

• Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

• Evidence of distant metastasis

• Prior chemotherapy, radiotherapy or surgery (except diagnostic) to primary tumor or nodes.

• Other previous or concomitant cancer.

• Pregnancy or lactation.

• Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, immune deficiency, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or emotional disturbance.