TPF Induction Chemotherapy vs PF Adjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC
- Conditions
- Locally Advanced Nasopharyngeal Carcinoma
- Interventions
- Drug: TPF+CCRTDrug: CCRT+PF
- Registration Number
- NCT03574324
- Lead Sponsor
- Guiyang Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 266
- Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
- Clinical staged as III，IVa（according to the American Joint Committee on Cancer(AJCC) 7th edition）
- Fertility women should ensure contraception during entry into the study.
- Age 18-69 years old.
- Karnofsky scale(KPS)≥70.
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- 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.
- Adequate renal function: creatinine clearance ≥60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent
- With distant metastasis.
- who had received prior chemotherapy or radiotherapy.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TPF+CCRT TPF+CCRT TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy CCRE+PF CCRT+PF Cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy followed by PF adjuvant chemotherapy
- Primary Outcome Measures
Name Time Method Progress-free survival(PFS) 3 years Progress-free survival(year) is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.
- Secondary Outcome Measures
Name Time Method Incidence of acute and late toxicity 3 years Incidence of acute toxicity（Grade1/2/3/4） is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme
Overall survival(OS) 3 years The OS(year) was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Distant metastasis-free survival(DMFS) 3 years The DMFS(year) is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
Overall response rate 12 weeks after completion of concurrent chemoradiotherapy Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1
Locoregional failure-free survival(LRFS) 3 years The LRFS(year) is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
Trial Locations
- Locations (1)
Cancer Hospital of Guizhou Medical University
🇨🇳Guiyang, 贵州省, China