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

NCT03574324 | Unknown Phase 3 DMC

• 1 other identifier: 20180602
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall survival(OS)

  3 years

• Locoregional failure-free survival(LRFS)

  3 years

• Distant metastasis-free survival(DMFS)

  3 years

• Overall response rate

  12 weeks after completion of concurrent chemoradiotherapy

• Incidence of acute and late toxicity

  3 years

Study Arms (2)

TPF+CCRT

EXPERIMENTAL

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

Drug: TPF+CCRT

CCRE+PF

OTHER

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

Drug: CCRT+PF

Interventions

TPF+CCRT DRUG

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

Also known as: Experimental group

TPF+CCRT

CCRT+PF DRUG

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

Also known as: Control group

CCRE+PF

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Guiyang Medical University: lead

Study Sites (1)

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yuanyuan Li, Master

  Guizhou Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Jin, Bachelor

CONTACT

0851-86512802; jinf8865@yeah.net

Yuanyuan Li, Master

CONTACT

0851-86512802; lilyuanyuan@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and neck cancer director, chief researcher, clinical professor

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: July 2, 2018
• Study Start: May 24, 2018
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)