Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma

Phase 3

• Conditions: Chemoradiation; Nasopharyngeal Carcinoma
• Interventions: Drug: PF (cisplatin and 5-fluorouracil) group; Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) group

• Registration Number: NCT01536223
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-20
• Status Verified: 2012-04
• Study Start: 2012-04
• Last Update Submitted: 2013-03-03
• Last Update Posted: 2013-03-05
• Primary Completion: 2013-12
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF group	PF (cisplatin and 5-fluorouracil) group	the group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy
TPF group	TPF (docetaxel plus cisplatin and 5-fluorouracil) group	TPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China