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GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Nasopharyngeal Diseases

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

gemcitabine and cisplatin

cisplatin and fluorouracil

IMRT

cisplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring gemcitabine, cisplatin, fluorouracil

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
Tumor staged as T1-4N2-3/T4N0-1M0（according to the 8th AJCC edition）
Male and no pregnant female
Age between 18-65
Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <2.0×upper limit of normal (ULN)
Adequate renal function: creatinine clearance ≥60 ml/min
Satisfactory performance status: Karnofsky scale (KPS) ≥ 70
Without radiotherapy or chemotherapy
Patients must give signed informed consent

Exclusion Criteria:

Evidence of relapse or distant metastasis
History of prior malignancy or previous treatment for NPC
Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
Pregnancy or lactation

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

gemcitabine and cisplatin

cisplatin and fluorouracil

Arm Description

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.

Patients receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.

Outcomes

Primary Outcome Measures

progress-free survival (PFS)

Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

Secondary Outcome Measures

Distant Metastasis-Free Survival (DMFS)

The DMFS 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 Survival (OS)

The OS 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 Relapse-Free Survival (LRRFS)

The LRRFS 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.

Number of participants with adverse events

Incidence of acute and late toxicity

Full Information

NCT ID

NCT03840421

First Posted

February 12, 2019

Last Updated

May 4, 2022

Sponsor

Sun Yat-sen University

Collaborators

Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangdong Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT03840421

Brief Title

GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma

Official Title

GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma：a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 3, 2019 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangdong Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen 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

The purpose of this study is to compare the survival and toxicity of GP (gemcitabine and cisplatin) vs. PF (cisplatin and fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal carcinoma( NPC ) patients.

Detailed Description

Patients presented with non-keratinizing NPC and stage T1-4N2-3/T4N0-1M0 are randomly assigned to receive GP (gemcitabine and cisplatin) or PF (cisplatin and fluorouracil) induction chemotherapy combined with concurrent chemoradiotherapy. Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m²) every three weeks for two cycles during radiotherapy. Patients in the investigational arm receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Patients in the control arm receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Our primary endpoint is progress-free survival (PFS). Secondary end points include distant metastasis-free survival (DMFS), overall survival (OS), locoregional relapse-free survival (LRRFS), initial response rates after treatments, toxic effects and quality of life (QoL).

6. Conditions and Keywords

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

Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Nasopharyngeal Diseases, Head and Neck Neoplasm

Keywords

gemcitabine, cisplatin, fluorouracil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

468 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

gemcitabine and cisplatin

Arm Type

Experimental

Arm Description

Arm Title

cisplatin and fluorouracil

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

gemcitabine and cisplatin

Other Intervention Name(s)

gemcitabine and cisplatin (GP)

Intervention Description

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

Intervention Type

Drug

Intervention Name(s)

cisplatin and fluorouracil

Other Intervention Name(s)

cisplatin and fluorouracil (PF)

Intervention Description

Patients receive fluorouracil (800mg/m2 d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

Intervention Type

Radiation

Intervention Name(s)

IMRT

Intervention Description

Intensity modulated-radiotherapy (IMRT) is given as 30～33 fraction with five daily fractions per week for 6-7 weeks to a total dose of 68～70 Gy to the primary tumor

Intervention Type

Drug

Intervention Name(s)

cisplatin

Other Intervention Name(s)

cisplatin（DDP）

Intervention Description

IMRT concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.

Primary Outcome Measure Information:

Title

progress-free survival (PFS)

Description

Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Distant Metastasis-Free Survival (DMFS)

Description

The DMFS 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 Survival (OS)

Description

The OS 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 Relapse-Free Survival (LRRFS)

Description

The LRRFS 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

Number of participants with adverse events

Description

Incidence of acute and late toxicity

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III Tumor staged as T1-4N2-3/T4N0-1M0（according to the 8th AJCC edition） Male and no pregnant female Age between 18-65 Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <2.0×upper limit of normal (ULN) Adequate renal function: creatinine clearance ≥60 ml/min Satisfactory performance status: Karnofsky scale (KPS) ≥ 70 Without radiotherapy or chemotherapy Patients must give signed informed consent Exclusion Criteria: Evidence of relapse or distant metastasis History of prior malignancy or previous treatment for NPC Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance. Pregnancy or lactation

Central Contact Person:

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

Peiyu Huang, MD,PhD

Phone

+86-20-87343379

huangpy@sysucc.org.cn

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

Ming-Yuan Chen, MD,PhD

Phone

+86-20-87343361

chenmy@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming-Yuan Chen, MD,PhD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rui-Hua Xu, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma

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