Status:
UNKNOWN
Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC
Lead Sponsor:
Chaosu Hu
Collaborating Sponsors:
Zhejiang Cancer Hospital
Jiangxi Provincial Cancer Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy and safety of sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant chemotherapy) with induction chemot...
Detailed Description
Patients with non-keratinizing NPC III-IVA (UICC/AJCC 8th edition) are randomly assigned to receive sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy + adjuvant c...
Eligibility Criteria
Inclusion
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type)
- Tumor staged as III-IVA (according to the 8th AJCC edition).
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
- Age between 18 and 65 years old.
- Adequate marrow: Neutrophil count ≥2000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.
- Adequate renal function: creatinine clearance ≥60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion
- Evidence of distant metastasis
- Prior chemotherapy, radiotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Other previous or concomitant cancer.
- Pregnancy or lactation.
- Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, immune deficiency, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or emotional disturbance.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT03366415
Start Date
January 1 2018
End Date
December 30 2024
Last Update
March 4 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032