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

Primary Purpose

Locally Advanced Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

TPF+CCRT

CCRT+PF

About this trial

This is an interventional treatment trial for Locally Advanced Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Cancer Hospital of Guizhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

TPF+CCRT

CCRE+PF

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Overall response rate

Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1

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

Full Information

NCT ID

NCT03574324

First Posted

June 2, 2018

Last Updated

June 19, 2018

Sponsor

Guiyang Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03574324

Brief Title

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

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 24, 2018 (Actual)

Primary Completion Date

May 24, 2023 (Anticipated)

Study Completion Date

May 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guiyang Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TPF+CCRT

Arm Type

Experimental

Arm Description

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

Arm Title

CCRE+PF

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

TPF+CCRT

Other Intervention Name(s)

Experimental group

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

CCRT+PF

Other Intervention Name(s)

Control group

Intervention Description

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

Primary Outcome Measure Information:

Title

Progress-free survival(PFS)

Description

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.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Overall survival(OS)

Description

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.

Time Frame

3 years

Title

Locoregional failure-free survival(LRFS)

Description

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.

Time Frame

3 years

Title

Distant metastasis-free survival(DMFS)

Description

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.

Time Frame

3 years

Title

Overall response rate

Description

Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1

Time Frame

12 weeks after completion of concurrent chemoradiotherapy

Title

Incidence of acute and late toxicity

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Feng Jin, Bachelor

Phone

0851-86512802

jinf8865@yeah.net

First Name & Middle Initial & Last Name or Official Title & Degree

Yuanyuan Li, Master

Phone

0851-86512802

lilyuanyuan@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuanyuan Li, Master

Organizational Affiliation

Guizhou Provincial Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Hospital of Guizhou Medical University

City

Guiyang

State/Province

贵州省

ZIP/Postal Code

550000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuanyuan Li, master

Phone

085186512802

lilyuanyuan@qq.com

First Name & Middle Initial & Last Name & Degree

Feng Jin, Bachelor

First Name & Middle Initial & Last Name & Degree

Weili Wu, Master

First Name & Middle Initial & Last Name & Degree

Jinhua Long, Master

First Name & Middle Initial & Last Name & Degree

Xiuling Luo, Bachelor

First Name & Middle Initial & Last Name & Degree

Xiuyun Gong, Bachelor

First Name & Middle Initial & Last Name & Degree

Hang Jiang, Master

First Name & Middle Initial & Last Name & Degree

Yanfang Cen, Bachelor

12. IPD Sharing Statement

Plan to Share IPD

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

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