IMRT and concurrent cisplatin: Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated radiotherapy (IMRT)
gemcitabine and cisplatin (Induction chemotherapy): Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy
Study summary
The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk locoregionally advanced nasopharyngeal carcinoma(NPC).
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-70 years old.
2. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
3. Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA\<4000copies/ml.
4. ECOG Performance status less or equal to 1.
5. Male and no pregnant female.
6. Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
7. 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.
8. Adequate renal function: creatinine clearance ≥ 60 ml/min.
9. Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
1. Patients have evidence of relapse or distant metastasis.
2. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
3. Treatment with palliative intent.
4. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
6. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
7. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
8. 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.
Primary outcome measure(s)
Progress-free survival(PFS) — 3 years defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
Trial sites (8)
Facility
City
Region
Status
Guangzhou Panyu Central Hospital
Guangzhou
Guangdong
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Zhongshan City People's Hospital
Zhongshan
Guangdong
The First Affiliated Hospital of Guangxi Medical University
Nanning
Guangxi
Cancer Hospital of Guizhou Province
Guiyang
Guizhou
Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
Wuhan
Hubei
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology;
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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