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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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ClinicalTrials.gov Identifier: NCT03557112
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Feng Jing, Guiyang Medical University

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Nimotuzumab Drug: Cisplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: the treatment group
TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy
Drug: Nimotuzumab
TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy
Other Name: Nimotuzumab lnjection

Active Comparator: the control group
TPF regimen induction chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy
Drug: Cisplatin
TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy
Other Name: cis-DDP; cis-Diammineplatinum(II) dichloride




Primary Outcome Measures :
  1. National Cancer Institute CTCAE v4.0 [ Time Frame: 1 year ]
    Acute toxicity of radiotherapy and chemotherapy


Secondary Outcome Measures :
  1. evaluation of immediate efficacy overall survival overall survival overall survival overall survival overall survival overall survival [ Time Frame: 1 year ]
    Evaluation of efficacy by RESIST1.1 standard

  2. overall survival [ Time Frame: 5 years ]
    Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST

  3. locoregional failure-free survival [ Time Frame: 5 years ]
    Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST

  4. progression-free survival [ Time Frame: 5 years ]
    Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557112


Contacts
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Contact: Feng Jin, Bachelor 86-13985124806 jinf8865@yeah.net
Contact: Weili Wu, master 86-13885124077 wwlmhy@163.com

Locations
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China, Guizhou
Cancer Hospital of Guizhou Medical University Recruiting
Guiyang, Guizhou, China, 550000
Contact: Feng Jin, Bachelor    86-13985124806    jinf8865@yahoo.com.cn   
Contact: Weili Wu, Master    86-13885124077    wwlmhy@163.com   
Sub-Investigator: Weili Wu, master         
Sub-Investigator: Yuanyuan Li, master         
Sub-Investigator: Jinhua Long, master         
Sub-Investigator: Xiuyun Gong, bachelor         
Sub-Investigator: Xiaoxiao Chen, bachelor         
Sub-Investigator: Yu Chen, master         
Sponsors and Collaborators
Guiyang Medical University
Investigators
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Study Chair: Feng Jin, Bachelor Guizhou Provincial Cancer Hospital
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Responsible Party: Feng Jing, Head and neck cancer director, chief researcher, clinical professor, Guiyang Medical University
ClinicalTrials.gov Identifier: NCT03557112    
Other Study ID Numbers: 20180604
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Feng Jing, Guiyang Medical University:
Locally Advanced Nasopharyngeal Carcinoma
nimotuzumab
chemoradiotherapy
cisplatin
Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Nimotuzumab
Antineoplastic Agents
Antineoplastic Agents, Immunological