Chemoradiation, Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma (NPC), cisplatin and 5-fluorouracil (PF), docetaxel,cisplatin and 5-fluorouracil(TPF), Neoadjuvant Chemotherapy, intensity modulated radiotherapy(IMRT)
Brief summary
Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.
Detailed description
For locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb),the investigators randomised assign to either 3 cycles of cisplatin plus 5-fluorouracil plus (PF) or 3 cycles of docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy. 21 days a cycle. After the neoadjuvant chemotherapy ,the patients will receive the intensity modulated radiotherapy(IMRT) with 2 cycles of concurrent chemotherapy of cisplatin 80mg/m2.
Interventions
DRUGPF (cisplatin and 5-fluorouracil) group
the group the patients using PF(cisplatin and 5-fluorouracil )neoadjuvant chemotherapy 3 cycles of neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 100mg/m2 and 5-fluorouracil 4000mg/m2 civ 120 hours And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.
DRUGTPF (docetaxel plus cisplatin and 5-fluorouracil) group
3 cycles of TPF neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2,cisplatin75mg/m2 and 5-fluorouracil 2400mg/m2 civ 96 hours . And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang University
Zhejiang Provincial People's Hospital
Sir Run Run Shaw Hospital
Wenzhou Medical University
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with newly histologically confirmed non-keratinizing carcinoma. 2. Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system) 3. No evidence of distant metastasis(M0) 4. Performance status:KPS\>70 5. With normal liver function test(ALT, AST\<1.5ULN) 6. Renal:creatinine clearance \>60ml/min 7. Without hematopathy,marrow:WBC\>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L. 8. With controled blood glucose for diabetes patients 9. Written informed consent
Exclusion criteria
1. WHO type I squamous cell carcinoma or adenocarcinoma 2. Age\>70 or \<18 3. With a history of renal disease 4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin0 5. Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the intended RT treatment volume) 6. Patient is pregnant or lactating . 7. Peripheral neuropathy 8. Emotional disturbance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year progress free survival(PFS) | 3 years after the inception assignment | PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival(OS) | 2 years ,3 years and 5 years after the inception of the assignment | the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to calculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups. |
| Adverse events | participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years | observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemotherapy ,chemoradiation and follow-up. |
| local control rate (LCR) | 1 year ,2 years,3 years and 5 years after the inception of the study | — |
Countries
China
Contacts
Primary ContactXiaozhong Chen, MD
Backup ContactWeifeng Qin, MD
Outcome results
None listed