TPF Induction Chemotherapy vs PF Adjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC

• Status: Recruiting
• Trial end date: 2023-05-24
• Target enrollment: 0
• Participant gender: All

Summary

Through randomized controlled phase III multicenter clinical trials, TPF induction chemotherapy vs. PF regimen adjuvant chemotherapy concurrently Radiotherapy and chemotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival rate and improve the quality of life.

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

Details

• Lead Sponsor: Guiyang Medical University
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).

2. Clinical staged as III，IVa（according to the American Joint Committee on Cancer(AJCC) 7th edition）

3. Fertility women should ensure contraception during entry into the study.

4. Age 18-69 years old.

5. Karnofsky scale(KPS)≥70.

6. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.

7. 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 ≤ULN.

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

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

Exclusion Criteria:

1. With distant metastasis.

2. who had received prior chemotherapy or radiotherapy.

3. patients have physical or mental illness, and by researchers believe that patients 4.can not be completely or fully understood in this study possible complications.

5.pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. 6.serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.