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
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Endostar, Nasopharyngeal Carcinoma, Chemoradiotherapy, Endostatin
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.
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
NCT ID
NCT03932266
First Posted
November 22, 2017
Last Updated
April 28, 2019
Sponsor
Jiangsu Cancer Institute & Hospital
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
Learn more about this trial
Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma
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