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Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma by AJCC V8 Stage

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Gemcitabine
Cisplatin
Intensity-modulated radiotherapy
Sponsored by
Fourth Affiliated Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma by AJCC V8 Stage focused on measuring Nimotuzumab, Nasopharyngeal Carcinoma, Induction Chemotherapy, Chemoradiation, Adjuvant Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 18 to 70. Pathological type: non-keratinizing carcinoma (World Health Organization criteria). Diagnosed with LANPC (stage III-IV, except for patients with T3N0)) according to the 8th edition clinical staging system of the American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC]. ECOG performance score: 0 to 1. Primary lesions can measurable. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula). Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. Exclusion Criteria: Primary lesions or lymph node have been operated (except of operation for biopsy). Previous Received other anti EGFR monoclonal antibody treatment;Previous chemotherapy or immunization therapy. Other malignant tumor. Participation in other interventional clinical trials within 1 month. History of Serious lung or heart disease. Pregnant or breast-feeding women and women who refused to take contraceptive method. Drug abuse or alcohol addiction. History of serious allergic or allergy. Refused or can't signed informed consent form. Other patients who are considered ineligible for the study by the investigator.

Sites / Locations

  • People's Hospital of BaiseRecruiting
  • Affiliated Hospital of Youjiang Medical University for NationalitiesRecruiting
  • Guilin Medical University, ChinaRecruiting
  • Nanxishan Hospital of Guangxi Zhuang Autonomous RegionRecruiting
  • the Fourth Affiliated Hospital of Guangxi Medical UniversityRecruiting
  • Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • The First People's Hospital of QinzhouRecruiting
  • Wuzhou Red Cross HospitalRecruiting
  • Liuzhou People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Nimotuzumab arm

Control

Arm Description

Patients will receive induction chemotherapy with nimotuzumab (200mg/w,weekly plus gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT. After 4-6 weeks of the completion of IMRT, adjuvant nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles.

Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT.

Outcomes

Primary Outcome Measures

overall survival(OS)
Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.OS will be measured by the Method of Kaplan and Meier.

Secondary Outcome Measures

Tumor control probability (TCP)
Tumor control probability is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Disease-free survival(DFS)
DFS is defined as the time from randomization to the first documented disease progression or death due to disease progression per RECIST 1.1. DFS will be measured by the Method of Kaplan and Meier.
Locoregional failure-free survival(LRRFS)
LRRFS is defined as the time from randomization to the date of locoregional relapse per RECIST 1.1. LRRFS will be measured by the Method of Kaplan and Meier.
Distant Metastasis-free survival(DMFS)
DMFS is defined as the time from randomization to the date of first distant metastasis. DMFS will be measured by the Method of Kaplan and Meier.
Incidence rate of investigator-reported adverse events (AEs)
Analysis of investigator-reported adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 and radiation therapy oncology group (RTOG) toxicity criteria.
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.

Full Information

First Posted
December 24, 2022
Last Updated
January 29, 2023
Sponsor
Fourth Affiliated Hospital of Guangxi Medical University
Collaborators
People's Hospital of Baise, Second Affiliated Hospital of Guangzhou Medical University, Nanxishan Hospital of Guangxi Zhuang Autonomous Region, Guilin Medical University, China, LiuZhou People's Hospital, The First People's Hospital of Qinzhou, Wuzhou Red Cross Hospital, Affiliated Hospital of Youjiang Medical University for Nationalities
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1. Study Identification

Unique Protocol Identification Number
NCT05717790
Brief Title
Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
Official Title
Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation and Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fourth Affiliated Hospital of Guangxi Medical University
Collaborators
People's Hospital of Baise, Second Affiliated Hospital of Guangzhou Medical University, Nanxishan Hospital of Guangxi Zhuang Autonomous Region, Guilin Medical University, China, LiuZhou People's Hospital, The First People's Hospital of Qinzhou, Wuzhou Red Cross Hospital, Affiliated Hospital of Youjiang Medical University for Nationalities

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. This is a multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma by AJCC V8 Stage
Keywords
Nimotuzumab, Nasopharyngeal Carcinoma, Induction Chemotherapy, Chemoradiation, Adjuvant Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Nimotuzumab arm
Arm Type
Experimental
Arm Description
Patients will receive induction chemotherapy with nimotuzumab (200mg/w,weekly plus gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT. After 4-6 weeks of the completion of IMRT, adjuvant nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT.
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Other Intervention Name(s)
h-R3, BIOMAb EGFR
Intervention Description
Drug: Nimotuzumab Experimental: Nimotuzumab arm Induction chemotherapy:Nimotuzumab 200mg will be given weekly for 6 cycles, started on day 1 of induction chemotherapy. Concurrent chemotherapy: Nimotuzumab 200mg/week in concurrent with IMRT. Adjuvant therapy: Nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles. Active Comparator: Control Nimotuzumab 200mg/week in concurrent with IMRT .
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
GEM
Intervention Description
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
DDP
Intervention Description
Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles. Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiotherapy
Other Intervention Name(s)
IMRT
Intervention Description
Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day
Primary Outcome Measure Information:
Title
overall survival(OS)
Description
Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.OS will be measured by the Method of Kaplan and Meier.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Tumor control probability (TCP)
Description
Tumor control probability is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Time Frame
5 years
Title
Disease-free survival(DFS)
Description
DFS is defined as the time from randomization to the first documented disease progression or death due to disease progression per RECIST 1.1. DFS will be measured by the Method of Kaplan and Meier.
Time Frame
5 years
Title
Locoregional failure-free survival(LRRFS)
Description
LRRFS is defined as the time from randomization to the date of locoregional relapse per RECIST 1.1. LRRFS will be measured by the Method of Kaplan and Meier.
Time Frame
5 years
Title
Distant Metastasis-free survival(DMFS)
Description
DMFS is defined as the time from randomization to the date of first distant metastasis. DMFS will be measured by the Method of Kaplan and Meier.
Time Frame
5 years
Title
Incidence rate of investigator-reported adverse events (AEs)
Description
Analysis of investigator-reported adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 and radiation therapy oncology group (RTOG) toxicity criteria.
Time Frame
5 years
Title
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Description
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18 to 70. Pathological type: non-keratinizing carcinoma (World Health Organization criteria). Diagnosed with LANPC (stage III-IV, except for patients with T3N0)) according to the 8th edition clinical staging system of the American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC]. ECOG performance score: 0 to 1. Primary lesions can measurable. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula). Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. Exclusion Criteria: Primary lesions or lymph node have been operated (except of operation for biopsy). Previous Received other anti EGFR monoclonal antibody treatment;Previous chemotherapy or immunization therapy. Other malignant tumor. Participation in other interventional clinical trials within 1 month. History of Serious lung or heart disease. Pregnant or breast-feeding women and women who refused to take contraceptive method. Drug abuse or alcohol addiction. History of serious allergic or allergy. Refused or can't signed informed consent form. Other patients who are considered ineligible for the study by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Lu, MD
Phone
+8607723815405
Email
1786734840@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Lu, MD
Organizational Affiliation
The Fourth Affiliated Hospital of Guangxi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
People's Hospital of Baise
City
Baise
State/Province
Guangxi
ZIP/Postal Code
533000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiliang Meng
Email
337468010@qq.com
Facility Name
Affiliated Hospital of Youjiang Medical University for Nationalities
City
Baise
State/Province
Guangxi
ZIP/Postal Code
533099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingzhuang Yi
Email
ytz20070101@163.com
Facility Name
Guilin Medical University, China
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meilian Liu
Email
liu.meilian@163.com
Facility Name
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongmei Wu
Email
wudongmei06@163.com
Facility Name
the Fourth Affiliated Hospital of Guangxi Medical University
City
Liuzhou
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xishan Chen, Master
Email
344135841@qq.com
Facility Name
Second Affiliated Hospital of Guangzhou Medical University
City
Nanjing
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Li
Email
13978896800@163.com
Facility Name
The First People's Hospital of Qinzhou
City
Qinzhou
State/Province
Guangxi
ZIP/Postal Code
535000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baoqing Yang
Email
460200267@qq.com
Facility Name
Wuzhou Red Cross Hospital
City
Wuzhou
State/Province
Guangxi
ZIP/Postal Code
543000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianquan Gao
Email
gjq2369712@sina.com
Facility Name
Liuzhou People's Hospital
City
Liuzhou
State/Province
Other (Non U.s.)
ZIP/Postal Code
545000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Wang
Email
wjszr2018@126.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Complete de-identified patient data set
IPD Sharing Time Frame
For 2 years started from 12 months after publication of the primary trial report.
IPD Sharing Access Criteria
Authoritative researchers who provide a methodologically sound proposal for individual participant data meta-analysis.

Learn more about this trial

Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma

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