Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma
NCT ID: NCT04437329
Last Updated: 2022-05-10
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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RECRUITING
PHASE3
352 participants
INTERVENTIONAL
2020-08-01
2029-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DNF-N
1. Induction chemotherapy:
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks
2. Concurrent chemoradiotherapy:
three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy
3. Radiotherapy: radical intense modulated radiation therapy
Docetaxel, nedaplatin, fluorouracil
Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
Nedaplatin
Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Intensity modulated-radiotherapy
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
DPF-P
1. Induction chemotherapy:
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous cisplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks
2. Concurrent chemoradiotherapy:
three cycles of 100 mg/m² cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy
3. Radiotherapy: radical intense modulated radiation therapy
Docetaxel, cisplatin, fluorouracil
Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Cisplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
Cisplatin
Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Intensity modulated-radiotherapy
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
Interventions
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Docetaxel, nedaplatin, fluorouracil
Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
Docetaxel, cisplatin, fluorouracil
Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Cisplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
Nedaplatin
Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Cisplatin
Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Intensity modulated-radiotherapy
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system
3. No evidence of distant metastasis (M0)
4. Age between 18-65
5. WBC≥4×10\^9/ l, platelet ≥ 100×10\^9/ l and hemoglobin ≥ 90g/l
6. With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)
7. With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)
8. Satisfactory performance status: KARNOFSKY scale (KPS) \> 70
9. Patients must give signed informed consent
Exclusion Criteria
2. Age \>65 or \< 18 years
3. Treatment with palliative intent
4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
5. History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes
6. History of previous radiotherapy
7. Pregnancy or lactation
8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance
18 Years
65 Years
ALL
No
Sponsors
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Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Responsible Party
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Jin-Quan Liu
President of Affiliated Tumor Hospital of Guangzhou Medical University
Principal Investigators
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Jinquan Liu, M.D
Role: STUDY_DIRECTOR
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Locations
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Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NPC-NDP
Identifier Type: -
Identifier Source: org_study_id
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