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出境医 / 临床实验 / Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma

Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma

Study Description
Brief Summary:
Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation: Intensity Modulated Radiation Therapy (IMRT) Phase 2

Detailed Description:
This study was a multicenter, prospective, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. A total of 73 patients with pathologically confirmed locoregionally advanced nasopharyngeal carcinoma would be enrolled. Patients were randomly divided into two groups, with 48 patients in the combination group and 25 patients in the control group. The combination group was treated with Induction and Concurrent Chemoradiotherapy combined with Endostar. The control group was treated with Induction and Concurrent Chemoradiotherapy. The short term efficacy and side effects of these treatments would be evaluated. The 1-year, 3-year progression-free survival and overall survival would be analyzed. This data of this study might provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with higher efficacy and low toxicity.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Experimental group
Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation
Drug: Endostar
Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.
Other Name: Recombinant human endostatin injection

Drug: Cisplatin
Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.

Drug: Docetaxel
Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.

Radiation: Intensity Modulated Radiation Therapy (IMRT)
IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions

Control group
Drug: Cisplatin Drug: Docetaxel Radiation
Drug: Cisplatin
Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.

Drug: Docetaxel
Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.

Radiation: Intensity Modulated Radiation Therapy (IMRT)
IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions

Outcome Measures
Primary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: Approximately 36 months ]
    Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause


Secondary Outcome Measures :
  1. objective response rate [ Time Frame: 18months ]
    Complete response (CR)+Partial response (PR) according to RECIST 1.1

  2. overall survival (OS) [ Time Frame: Approximately 36 months ]
    Overall survival was defined as the time from randomization to death from any cause

  3. adverse event (AE) [ Time Frame: Approximately 36 months ]
    adverse event according to NCI-CTCAE (5.0)


Eligibility Criteria
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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. Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
  2. No chemotherapy, immunotherapy, radiotherapy treatment history.
  3. No evidence of distant metastasis
  4. Eastern Cooperative Oncology Group performance score 0-1
  5. Normal bone marrow function: white blood cell count > 3.5 × 109 / L, hemoglobin > 90 g / L and platelet count > 100 × 109 / L.
  6. Normal liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) <1.5 times the upper limit of normal (ULN), and alkaline phosphatase (ALP) < 2.5 × ULN
  7. Normal renal function: creatinine clearance > 60 ml/min.
  8. The patient must be informed of the basic content of the study and sign an informed consent form.

Exclusion Criteria:

  1. The pathological type is keratinized squamous cell carcinoma or basal squamous cell carcinoma.
  2. Treatment is palliative.
  3. A history of malignant tumors, except for well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ.
  4. Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment).
  5. Previous radiation therapy (except for non-melanoma skin cancer with a previous lesion outside the target area of radiotherapy).
  6. Primary and cervical metastatic lesions have received chemotherapy or surgery (except for diagnostic treatment).
  7. Having other serious illnesses may result in greater risk or affect the compliance of the trial. For example: kidney disease, chronic hepatitis, control of unsatisfactory diabetes (fasting blood glucose > 1.5 × ULN), and mental illness.
  8. A history of severe heart disease, including: cardiac function ≥ standard II, unstable angina, myocardial infarction, arrhythmia - antiarrhythmic drug therapy (except beta-blockers or digoxin), Uncontrollable hypertension.
  9. According to the investigator's judgment, there are people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
  10. Patients with a major bleeding tendency in the primary nasopharyngeal tumors.
Contacts and Locations

Contacts
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Contact: Xia He, M.D., Ph.D. 8625-83283597 hexia206@163.com
Contact: Juying Liu, M.D., Ph.D. 8625-83283596 peteadam@yeah.net

Sponsors and Collaborators
Jiangsu Cancer Institute & Hospital
Investigators
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Principal Investigator: Xia He, M.D., Ph.D. Jiangsu Cancer Institute & Hospital
Tracking Information
First Submitted Date  ICMJE November 22, 2017
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date April 30, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2019)
progression-free survival (PFS) [ Time Frame: Approximately 36 months ]
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2019)
  • objective response rate [ Time Frame: 18months ]
    Complete response (CR)+Partial response (PR) according to RECIST 1.1
  • overall survival (OS) [ Time Frame: Approximately 36 months ]
    Overall survival was defined as the time from randomization to death from any cause
  • adverse event (AE) [ Time Frame: Approximately 36 months ]
    adverse event according to NCI-CTCAE (5.0)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma
Official Title  ICMJE Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
Brief Summary Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma.
Detailed Description This study was a multicenter, prospective, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. A total of 73 patients with pathologically confirmed locoregionally advanced nasopharyngeal carcinoma would be enrolled. Patients were randomly divided into two groups, with 48 patients in the combination group and 25 patients in the control group. The combination group was treated with Induction and Concurrent Chemoradiotherapy combined with Endostar. The control group was treated with Induction and Concurrent Chemoradiotherapy. The short term efficacy and side effects of these treatments would be evaluated. The 1-year, 3-year progression-free survival and overall survival would be analyzed. This data of this study might provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with higher efficacy and low toxicity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Drug: Endostar
    Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.
    Other Name: Recombinant human endostatin injection
  • Drug: Cisplatin
    Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
  • Drug: Docetaxel
    Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.
  • Radiation: Intensity Modulated Radiation Therapy (IMRT)
    IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions
Study Arms  ICMJE
  • Experimental: Experimental group
    Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation
    Interventions:
    • Drug: Endostar
    • Drug: Cisplatin
    • Drug: Docetaxel
    • Radiation: Intensity Modulated Radiation Therapy (IMRT)
  • Control group
    Drug: Cisplatin Drug: Docetaxel Radiation
    Interventions:
    • Drug: Cisplatin
    • Drug: Docetaxel
    • Radiation: Intensity Modulated Radiation Therapy (IMRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2019)
73
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
  2. No chemotherapy, immunotherapy, radiotherapy treatment history.
  3. No evidence of distant metastasis
  4. Eastern Cooperative Oncology Group performance score 0-1
  5. Normal bone marrow function: white blood cell count > 3.5 × 109 / L, hemoglobin > 90 g / L and platelet count > 100 × 109 / L.
  6. Normal liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) <1.5 times the upper limit of normal (ULN), and alkaline phosphatase (ALP) < 2.5 × ULN
  7. Normal renal function: creatinine clearance > 60 ml/min.
  8. The patient must be informed of the basic content of the study and sign an informed consent form.

Exclusion Criteria:

  1. The pathological type is keratinized squamous cell carcinoma or basal squamous cell carcinoma.
  2. Treatment is palliative.
  3. A history of malignant tumors, except for well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ.
  4. Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment).
  5. Previous radiation therapy (except for non-melanoma skin cancer with a previous lesion outside the target area of radiotherapy).
  6. Primary and cervical metastatic lesions have received chemotherapy or surgery (except for diagnostic treatment).
  7. Having other serious illnesses may result in greater risk or affect the compliance of the trial. For example: kidney disease, chronic hepatitis, control of unsatisfactory diabetes (fasting blood glucose > 1.5 × ULN), and mental illness.
  8. A history of severe heart disease, including: cardiac function ≥ standard II, unstable angina, myocardial infarction, arrhythmia - antiarrhythmic drug therapy (except beta-blockers or digoxin), Uncontrollable hypertension.
  9. According to the investigator's judgment, there are people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
  10. Patients with a major bleeding tendency in the primary nasopharyngeal tumors.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xia He, M.D., Ph.D. 8625-83283597 hexia206@163.com
Contact: Juying Liu, M.D., Ph.D. 8625-83283596 peteadam@yeah.net
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932266
Other Study ID Numbers  ICMJE Endo-Naso-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Xia He, Jiangsu Cancer Institute & Hospital
Study Sponsor  ICMJE Jiangsu Cancer Institute & Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xia He, M.D., Ph.D. Jiangsu Cancer Institute & Hospital
PRS Account Jiangsu Cancer Institute & Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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