Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized,controlled,prospective phase III clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University; Zhao Chong
• Treatments: Capecitabine; Cisplatin

Criteria

Inclusion Criteria:

• Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)

• Clinical stage III~IVb(UICC/AJCC 7th)

• Meet at least one factor below :1 primary tumor SUVmax>10 in 18F-FDG PET/CT;2 T3-4N2M0; 5 T1-4N3M0;6 EBV-DNA PCR quantitative>2×10E4 copy/l(pre-treatment).

• No distant metastasis

• Karnofsky Performance Status Scale≥70

• WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L

• ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min

• Sign the informed consent.

Exclusion Criteria:

• Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas

• Younger than 18 years old or older than 70 years old

• Are receiving other drugs treanment

• kidney disease

• Have suffered from other tumor or now suffering from other tumor

• Have recieved chemotherapy or radiotherapy

• Pregnancy or lactation

• unstable heart disease need timely treatment

• Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes