Status:
COMPLETED
Reduced Target Delineation and Radiation Doses Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
Xiayun He, MD
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
To determine the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation and radiation doses IMRT for patients with loc...
Detailed Description
Although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment related toxicities...
Eligibility Criteria
Inclusion
- Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
- Stage Ⅲ-ⅣB disease (AJCC/UICC 2010)
- KPS more than 70
- Life expectancy of more than 6 months
- Signed written informed consent
- Adequate organ function including the following:
- Absolute neutrophil count (ANC) \>= 1.5 \* 109/l Platelets count \>= 100 \* 109/l Hemoglobin \>= 10 g/dl AST and ALT \<= 2.5 times institutional upper limit of normal (ULN) Total bilirubin \<= 1.5 times institutional ULN Creatinine clearance \>= 50 ml/min Serum creatine \<= 1 times ULN
Exclusion
- Evidence of distant metastasis
- Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03389295
Start Date
January 1 2010
End Date
April 1 2019
Last Update
December 16 2019
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032