Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

— ESNCCT  

Official title:

Cisplatin and 5-fluorouracil(PF) or Docetaxel,Cisplatin and 5-fluorouracil (TPF) Neoadjuvant Chemotherapy With Chemoradiation Therapy for Locally Advanced Nasopharyngeal Carcinoma--A Randomised Prospective Multicenter Phase 3 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01536223
• Other study ID #: ZhejiangCH13
• Status: Recruiting
• Phase: Phase 3
• First received: February 13, 2012
• Last updated: March 3, 2013
• Start date: April 2012
• Est. completion date: February 2015

Study information

• Verified date: April 2012
• Source: Zhejiang Cancer Hospital
• Contact: Xiaozhong Chen, MD
• Phone: 86-571-88122098
• Email: cxzfyun[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Chemoradiation
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• PF (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.
• TPF (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.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (6)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital, Wenzhou Medical University, Zhejiang Provincial People’s Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years after the inception assignment	No
Secondary	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.	2 years ,3 years and 5 years after the inception of the assignment	No
Secondary	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.	participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years	Yes
Secondary	local control rate (LCR)		1 year ,2 years,3 years and 5 years after the inception of the study	No