Clinical trial NCT03574324: TPF Induction Chemotherapy vs PF Adjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC
Official title: A Multicenter, Randomized Controlled Phase III Clinical Trial of TPF Induction Chemotherapy Versus PF Adjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Locally Advanced Nasopharyngeal Carcinoma
Lead sponsor: Guiyang Medical University
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Progress-free survival(PFS)
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 3 years
measure: Locoregional failure-free survival(LRFS)
timeFrame: 3 years
measure: Distant metastasis-free survival(DMFS)
timeFrame: 3 years
measure: Overall response rate
timeFrame: 12 weeks after completion of concurrent chemoradiotherapy
measure: Incidence of acute and late toxicity
timeFrame: 3 years
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Cancer Hospital of Guizhou Medical University
state: 贵州省
Study officials:
affiliation: Guizhou Provincial Cancer Hospital
name: Yuanyuan Li, Master
role: PRINCIPAL_INVESTIGATOR
References: