Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma
Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
1 other identifier
interventional
73
0 countries
N/A
Brief Summary
Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2019
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2017
CompletedFirst Posted
Study publicly available on registry
April 30, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedApril 30, 2019
April 1, 2019
3.3 years
November 22, 2017
April 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Approximately 36 months
Secondary Outcomes (3)
objective response rate
18months
overall survival (OS)
Approximately 36 months
adverse event (AE)
Approximately 36 months
Study Arms (2)
Experimental group
EXPERIMENTALDrug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation
Control group
OTHERDrug: Cisplatin Drug: Docetaxel Radiation
Interventions
Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.
Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.
IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xia He, M.D., Ph.D.
Jiangsu Cancer Institute & Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of radiotherapy department
Study Record Dates
First Submitted
November 22, 2017
First Posted
April 30, 2019
Study Start
June 1, 2019
Primary Completion
September 1, 2022
Study Completion
September 1, 2023
Last Updated
April 30, 2019
Record last verified: 2019-04