Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma

Zhejiang Cancer Hospital400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Chemoradiation Nasopharyngeal Carcinoma

Interventions

PF (cisplatin and 5-fluorouracil) groupDRUG

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.

TPF (docetaxel plus cisplatin and 5-fluorouracil) groupDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

3-year progress free survival(PFS)

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.

Time frame: 3 years after the inception assignment

Secondary Outcomes

overall survival(OS)

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.

Time frame: 2 years ,3 years and 5 years after the inception of the assignment

Adverse events

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.

Time frame: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years

local control rate (LCR)

Time frame: 1 year ,2 years,3 years and 5 years after the inception of the study

Central Contacts

Xiaozhong Chen, MD

CONTACT

86-571-88122098 cxzfyun@sina.com

Weifeng Qin, MD

CONTACT

86-571-88122092 qinweifeng@yahoo.com.cn

Data from ClinicalTrials.gov

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