Status:
UNKNOWN
Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Fudan University
West China Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (CCRT) with CCRT alone in patients with locoregionally advanced nasopharyngeal ...
Detailed Description
Patients Patients with non-keratinizing NPC T3-4N1M0/TxN2-3M0 (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy plus CCRT or CCRT alone. Patients in both groups receive c...
Eligibility Criteria
Inclusion
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
- Tumor staged as T3-4N1/N2-3 (according to the 7th AJCC edition).
- No evidence of distant metastasis (M0).
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
- Adequate marrow: leucocyte count ≥ 4000/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 ≤ ULN.
- 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
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age \> 65 or \< 18.
- Treatment with palliative intent.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT01872962
Start Date
November 1 2013
End Date
November 1 2020
Last Update
April 24 2018
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060