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

Guiyang Medical University

Status and phase: Unknown; Phase 3

Conditions: Locally Advanced Nasopharyngeal Carcinoma

Treatments: Drug: CCRT+PF; Drug: TPF+CCRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03574324

20180602

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

266 participants in 2 patient groups

TPF+CCRT

Experimental group

Description:

TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy

Treatment:

Drug: TPF+CCRT

CCRE+PF

Other group

Description:

Cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy followed by PF adjuvant chemotherapy

Treatment:

Drug: CCRT+PF