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By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy for Locally Advanced NPC

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Cisplatin
Sponsored by
Guiyang Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Locally Advanced Nasopharyngeal Carcinoma, nimotuzumab, chemoradiotherapy, cisplatin

Eligibility Criteria

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

Inclusion Criteria:

  1. The pathological type is non-keratinizing cancer (according to the World Health Organization, WHO pathological classification).
  2. The stage is graded by TxNxM0 (according to the eighth edition of the AJCC staging standard).
  3. Age: Between 18 to 70.
  4. EGFR, which is performed by biopsy immunohistochemical examination, shows positive.
  5. Functional Status: Karnofsky Scale (KPS) > 70.
  6. Normal Bone Marrow Function: White blood cell count > 4×109/L, hemoglobin >90g/L, and platelet count >100×109/L.
  7. Normal Liver Function: Alanine Tminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5 times the upper limit of normal (ULN), while alkaline phosphatase (ALP) < 2.5 x ULN and bilirubin < ULN.
  8. Normal Renal Function: creatinine clearance > 60 ml/min.
  9. The patient must be informed of the basic content of the study and sign an informed consent.

Exclusion Criteria:

  1. Patients with a prior history of malignant tumors, except well-treated basal cell carcinoma or squamous-cell carcinoma, and cervical carcinoma in situ.
  2. Women during pregnancy or breastfeeding (for women of child-bearing age, pregnancy test should be considered; effective contraception should be emphasized during treatment).
  3. Patients received radiotherapy, chemotherapy, and immunological targeted therapies (non-melanoma skin cancers with previous lesions outside the target of radiotherapy are excluded).
  4. Patients received treatments for primary lesions and metastatic cervical lesions (except diagnostic treatment).
  5. Patients with other serious diseases which may bring greater risk or affect the compliance of the trial. For example: unstable heart disease requiring treatment, kidney disease, chronic hepatitis, uncontrolled diabetes (fasting blood glucose >1.5 x ULN), and mental illness.

Sites / Locations

  • Cancer Hospital of Guizhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the treatment group

the control group

Arm Description

TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy

TPF regimen induction chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy

Outcomes

Primary Outcome Measures

National Cancer Institute CTCAE v4.0
Acute toxicity of radiotherapy and chemotherapy

Secondary Outcome Measures

evaluation of immediate efficacy overall survival overall survival overall survival overall survival overall survival overall survival
Evaluation of efficacy by RESIST1.1 standard
overall survival
Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST
locoregional failure-free survival
Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST
progression-free survival
Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST

Full Information

First Posted
June 4, 2018
Last Updated
October 31, 2018
Sponsor
Guiyang Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03557112
Brief Title
By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy for Locally Advanced NPC
Official Title
Prospective, Multicenter, and Nonrandomized Phase II Clinical Study on the Treatment of Locally Advanced NPC By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is aimed to investigate the short-term efficacy and toxicities of local advanced nasopharyngeal carcinoma (NPC) treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and cisplatin concurrent chemoradiotherapy.
Detailed Description
TPF program is currently the local advanced nasopharyngeal carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin, direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients.In this study, Phase II clinical trials were performed. Patients with locally advanced local advanced nasopharyngeal carcinoma were nonrandomly divided into experimental group and control group.The trial group was treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and chemotherapy. The control group was treated with TPF regimen induction chemotherapy combined with Cisplatin concurrent radiotherapy and chemotherapy.observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Locally Advanced Nasopharyngeal Carcinoma, nimotuzumab, chemoradiotherapy, cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the treatment group
Arm Type
Experimental
Arm Description
TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy
Arm Title
the control group
Arm Type
Active Comparator
Arm Description
TPF regimen induction chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Other Intervention Name(s)
Nimotuzumab lnjection
Intervention Description
TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
cis-DDP; cis-Diammineplatinum(II) dichloride
Intervention Description
TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy
Primary Outcome Measure Information:
Title
National Cancer Institute CTCAE v4.0
Description
Acute toxicity of radiotherapy and chemotherapy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
evaluation of immediate efficacy overall survival overall survival overall survival overall survival overall survival overall survival
Description
Evaluation of efficacy by RESIST1.1 standard
Time Frame
1 year
Title
overall survival
Description
Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST
Time Frame
5 years
Title
locoregional failure-free survival
Description
Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST
Time Frame
5 years
Title
progression-free survival
Description
Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST
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: The pathological type is non-keratinizing cancer (according to the World Health Organization, WHO pathological classification). The stage is graded by TxNxM0 (according to the eighth edition of the AJCC staging standard). Age: Between 18 to 70. EGFR, which is performed by biopsy immunohistochemical examination, shows positive. Functional Status: Karnofsky Scale (KPS) > 70. Normal Bone Marrow Function: White blood cell count > 4×109/L, hemoglobin >90g/L, and platelet count >100×109/L. Normal Liver Function: Alanine Tminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5 times the upper limit of normal (ULN), while alkaline phosphatase (ALP) < 2.5 x ULN and bilirubin < ULN. Normal Renal Function: creatinine clearance > 60 ml/min. The patient must be informed of the basic content of the study and sign an informed consent. Exclusion Criteria: Patients with a prior history of malignant tumors, except well-treated basal cell carcinoma or squamous-cell carcinoma, and cervical carcinoma in situ. Women during pregnancy or breastfeeding (for women of child-bearing age, pregnancy test should be considered; effective contraception should be emphasized during treatment). Patients received radiotherapy, chemotherapy, and immunological targeted therapies (non-melanoma skin cancers with previous lesions outside the target of radiotherapy are excluded). Patients received treatments for primary lesions and metastatic cervical lesions (except diagnostic treatment). Patients with other serious diseases which may bring greater risk or affect the compliance of the trial. For example: unstable heart disease requiring treatment, kidney disease, chronic hepatitis, uncontrolled diabetes (fasting blood glucose >1.5 x ULN), and mental illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Jin, Bachelor
Phone
86-13985124806
Email
jinf8865@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Wu, master
Phone
86-13885124077
Email
wwlmhy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Jin, Bachelor
Organizational Affiliation
Guizhou Provincial Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Jin, Bachelor
Phone
86-13985124806
Email
jinf8865@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Weili Wu, Master
Phone
86-13885124077
Email
wwlmhy@163.com
First Name & Middle Initial & Last Name & Degree
Weili Wu, master
First Name & Middle Initial & Last Name & Degree
Yuanyuan Li, master
First Name & Middle Initial & Last Name & Degree
Jinhua Long, master
First Name & Middle Initial & Last Name & Degree
Xiuyun Gong, bachelor
First Name & Middle Initial & Last Name & Degree
Xiaoxiao Chen, bachelor
First Name & Middle Initial & Last Name & Degree
Yu Chen, master

12. IPD Sharing Statement

Plan to Share IPD
No

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By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy for Locally Advanced NPC

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