Two Cycles Versus Three Cyclle of CCRT for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma

• Status: Unknown status
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II trial to study the effectiveness of two cycles versus three cycles of Concurrent Chemoradiotherapy in treating patients with Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma based on pretreatment plasma EBV DNA.

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

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III

• Original clinical staged as T3-4N0-3 M0 or any T、N2-3M0（according to the 7th AJCC edition）

• No evidence of distant metastasis (M0)

• Pretreatment Plasm EB Virus DNA<4000copies/ml

• Male and no pregnant female

• Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1

• WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L

• With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)

• With normal renal function test (Creatinine ≤ 1.5×ULN)

Exclusion Criteria:

• Patients have evidence of relapse or distant metastasis

• Histologically confirmed keratinizing squamous cell carcinoma (WHO I)

• Receiving radiotherapy or chemotherapy previously

• The presence of uncontrolled life-threatening illness

• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.

• Receiving other ways of anti-cancer therapy.

• Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.