By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy for Locally Advanced NPC
NCT ID: NCT03557112
Last Updated: 2018-11-02
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
180 participants
INTERVENTIONAL
2018-06-01
2021-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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the treatment group
TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy
Nimotuzumab
TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy
the control group
TPF regimen induction chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy
Cisplatin
TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy
Interventions
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Nimotuzumab
TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy
Cisplatin
TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The stage is graded by TxNxM0 (according to the eighth edition of the AJCC staging standard).
3. Age: Between 18 to 70.
4. EGFR, which is performed by biopsy immunohistochemical examination, shows positive.
5. Functional Status: Karnofsky Scale (KPS) \> 70.
6. Normal Bone Marrow Function: White blood cell count \> 4×109/L, hemoglobin \>90g/L, and platelet count \>100×109/L.
7. Normal Liver Function: Alanine Tminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5 times the upper limit of normal (ULN), while alkaline phosphatase (ALP) \< 2.5 x ULN and bilirubin \< ULN.
8. Normal Renal Function: creatinine clearance \> 60 ml/min.
9. The patient must be informed of the basic content of the study and sign an informed consent.
Exclusion Criteria
2. Women during pregnancy or breastfeeding (for women of child-bearing age, pregnancy test should be considered; effective contraception should be emphasized during treatment).
3. Patients received radiotherapy, chemotherapy, and immunological targeted therapies (non-melanoma skin cancers with previous lesions outside the target of radiotherapy are excluded).
4. Patients received treatments for primary lesions and metastatic cervical lesions (except diagnostic treatment).
5. Patients with other serious diseases which may bring greater risk or affect the compliance of the trial. For example: unstable heart disease requiring treatment, kidney disease, chronic hepatitis, uncontrolled diabetes (fasting blood glucose \>1.5 x ULN), and mental illness.
18 Years
70 Years
ALL
No
Sponsors
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Guiyang Medical University
OTHER
Responsible Party
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Feng Jing
Head and neck cancer director, chief researcher, clinical professor
Principal Investigators
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Feng Jin, Bachelor
Role: STUDY_CHAIR
Guizhou Provincial Cancer Hospital
Locations
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Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20180604
Identifier Type: -
Identifier Source: org_study_id
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