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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Endostar
Cisplatin
Docetaxel
Intensity Modulated Radiation Therapy (IMRT)
Sponsored by
Jiangsu Cancer Institute & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Endostar, Nasopharyngeal Carcinoma, Chemoradiotherapy, Endostatin

Eligibility Criteria

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

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Experimental group

    Control group

    Arm Description

    Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation

    Drug: Cisplatin Drug: Docetaxel Radiation

    Outcomes

    Primary Outcome Measures

    progression-free survival (PFS)
    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

    objective response rate
    Complete response (CR)+Partial response (PR) according to RECIST 1.1
    overall survival (OS)
    Overall survival was defined as the time from randomization to death from any cause
    adverse event (AE)
    adverse event according to NCI-CTCAE (5.0)

    Full Information

    First Posted
    November 22, 2017
    Last Updated
    April 28, 2019
    Sponsor
    Jiangsu Cancer Institute & Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03932266
    Brief Title
    Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma
    Official Title
    Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2019 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Jiangsu Cancer Institute & Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasopharyngeal Carcinoma
    Keywords
    Endostar, Nasopharyngeal Carcinoma, Chemoradiotherapy, Endostatin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    73 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Drug: Cisplatin Drug: Docetaxel Radiation
    Intervention Type
    Drug
    Intervention Name(s)
    Endostar
    Other Intervention Name(s)
    Recombinant human endostatin injection
    Intervention Description
    Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Intervention Description
    Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel
    Intervention Description
    Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.
    Intervention Type
    Radiation
    Intervention Name(s)
    Intensity Modulated Radiation Therapy (IMRT)
    Intervention Description
    IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions
    Primary Outcome Measure Information:
    Title
    progression-free survival (PFS)
    Description
    Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
    Time Frame
    Approximately 36 months
    Secondary Outcome Measure Information:
    Title
    objective response rate
    Description
    Complete response (CR)+Partial response (PR) according to RECIST 1.1
    Time Frame
    18months
    Title
    overall survival (OS)
    Description
    Overall survival was defined as the time from randomization to death from any cause
    Time Frame
    Approximately 36 months
    Title
    adverse event (AE)
    Description
    adverse event according to NCI-CTCAE (5.0)
    Time Frame
    Approximately 36 months

    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: Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma; No chemotherapy, immunotherapy, radiotherapy treatment history. No evidence of distant metastasis Eastern Cooperative Oncology Group performance score 0-1 Normal bone marrow function: white blood cell count > 3.5 × 109 / L, hemoglobin > 90 g / L and platelet count > 100 × 109 / L. 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 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 form. Exclusion Criteria: The pathological type is keratinized squamous cell carcinoma or basal squamous cell carcinoma. Treatment is palliative. A history of malignant tumors, except for well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ. Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment). Previous radiation therapy (except for non-melanoma skin cancer with a previous lesion outside the target area of radiotherapy). Primary and cervical metastatic lesions have received chemotherapy or surgery (except for diagnostic treatment). 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. 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. 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. Patients with a major bleeding tendency in the primary nasopharyngeal tumors.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xia He, M.D., Ph.D.
    Phone
    8625-83283597
    Email
    hexia206@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Juying Liu, M.D., Ph.D.
    Phone
    8625-83283596
    Email
    peteadam@yeah.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xia He, M.D., Ph.D.
    Organizational Affiliation
    Jiangsu Cancer Institute & Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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