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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: TPF+CCRT; Drug: CCRT+PF

• Study Type: Interventional
• Enrollment (Anticipated): 266
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • 贵州省
    • Guiyang, 贵州省, China, 550000
      • Recruiting
      • Cancer Hospital of Guizhou Medical University
      • Sub-Investigator: Hang Jiang, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPF+CCRT; TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy	Drug: TPF+CCRT; Patients receive Neoadjuvant Docetaxel (75mg/m2 on day1 03:30-04:30) and cisplatin (75mg/m2 on day 1-5 10:00-22:00) and 5-FU(750mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 10:00-22:00)every 21 days for three cycles during radiotherapy; Other Names: Experimental group
Other: CCRE+PF; Cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy followed by PF adjuvant chemotherapy	Drug: CCRT+PF; Patients receive concurrent cisplatin (100mg/m2 on day1 10:00-22:00)every 21 days for three cycles during radiotherapy followed by adjuvant cisplatin (80mg/m2 on day 1-5 10:00-22:00) and 5-FU(800mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progress-free survival(PFS)	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival(OS)	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.	3 years
Locoregional failure-free survival(LRFS)	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.	3 years
Distant metastasis-free survival(DMFS)	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.	3 years
Overall response rate	Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1	12 weeks after completion of concurrent chemoradiotherapy
Incidence of acute and late toxicity	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	3 years

Collaborators and Investigators

• Sponsor: Guiyang Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2018
• Primary Completion (Anticipated): May 24, 2023
• Study Completion (Anticipated): May 24, 2023

Study Registration Dates

• First Submitted: June 2, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: 20180602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No