Status:
UNKNOWN
Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC
Lead Sponsor:
Fuzhou General Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Nasopharyngeal carcinoma (NPC) is a malignant tumor that originates in nasopharyngeal epithelial cells. It is common in southern China and Southeast Asia, but the incidence rate is low in most parts o...
Eligibility Criteria
Inclusion
- Age, 18-75 years old.
- Patients with newly histologically confirmed NPC.
- WHO Type Ⅱ and Ⅲ.
- Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition).
- No serious organ dysfunction of heart, lung, liver, kidney.
- No distant metastasis.
- Hematological examinations:WBC≥3.5×109/L, NEUT#≥1.5×109/L, PLT≥90×109/L, HB≥90g/L.
- 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 ≤1.5×ULN，creatinine clearance ≥60 ml/min.
- Patients must be given written informed consent.
Exclusion
- age \>75 years or \<18years.
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- History of previous radiotherapy and chemotherapy.
- Known or suspected to be allergic to platinum and Nab-paclitaxel.
- Pregnancy or lactation.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
- Peripheral sensory neuropathy\> grade 1.
- Uncontrolled heart clinical symptoms or diseases.
Key Trial Info
Start Date :
July 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04015661
Start Date
July 9 2019
End Date
June 1 2022
Last Update
July 11 2019
Active Locations (1)
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1
No. 156, North Road, Xierhuan Road
Fuzhou, Fujian, China