Status:
COMPLETED
Nedaplatin in Treatment for Nasopharyngeal Carcinoma
Lead Sponsor:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal...
Detailed Description
This is a prospective, phase II clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined wi...
Eligibility Criteria
Inclusion
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system
- No evidence of distant metastasis (M0)
- Age between 18-65
- WBC≥4×10\^9/ l, platelet ≥ 100×10\^9/ l and hemoglobin ≥ 90g/l
- With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)
- With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)
- Satisfactory performance status: KARNOFSKY scale (KPS) \> 70
- Patients must give signed informed consent
Exclusion
- Treatment with palliative intent
- The primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes)
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
- History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes
- History of previous radiotherapy
- Pregnancy or lactation
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04834206
Start Date
May 1 2021
End Date
May 1 2022
Last Update
May 10 2022
Active Locations (1)
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1
Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical Universityedical University
Guangzhou, Guangdong, China, 510095