Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma
NCT ID: NCT03932266
Last Updated: 2019-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
73 participants
INTERVENTIONAL
2019-06-30
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation
Endostar
Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.
Cisplatin
Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
Docetaxel
Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.
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
Cisplatin
Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
Docetaxel
Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.
Intensity Modulated Radiation Therapy (IMRT)
IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions
Interventions
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Endostar
Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.
Cisplatin
Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
Docetaxel
Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.
Intensity Modulated Radiation Therapy (IMRT)
IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Jiangsu Cancer Institute & Hospital
OTHER
Responsible Party
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Dr. Xia He
Head of radiotherapy department
Principal Investigators
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Xia He, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Cancer Institute & Hospital
Central Contacts
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Other Identifiers
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Endo-Naso-001
Identifier Type: -
Identifier Source: org_study_id