Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma (ESNCCT)
|ClinicalTrials.gov Identifier: NCT01536223|
Recruitment Status : Unknown
Verified April 2012 by Zhejiang Cancer Hospital.
Recruitment status was: Recruiting
First Posted : February 20, 2012
Last Update Posted : March 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chemoradiation Nasopharyngeal Carcinoma||Drug: PF (cisplatin and 5-fluorouracil) group Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) group||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||February 2015|
Active Comparator: PF group
the group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy
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.
Other Name: Active Comparator group
Experimental: TPF group
TPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy
Drug: 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.
Other Name: Experiment group
- 3-year progress free survival(PFS) [ Time Frame: 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.
- overall survival(OS) [ Time Frame: 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 [ 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 ]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) [ Time Frame: 1 year ,2 years,3 years and 5 years after the inception of the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536223
|Contact: Xiaozhong Chen, MDemail@example.com|
|Contact: Weifeng Qin, MDfirstname.lastname@example.org|
|Zhejiang Cancer Hospital||Recruiting|
|Hangzhou, Zhejiang, China, 310022|
|Contact: Xiaozhong Chen, MD 86-571-88122098 email@example.com|
|Contact: Weifeng Qin, MD 86-571-88122091 firstname.lastname@example.org|
|Principal Investigator: Xiaozhong Chen, MD|
|Principal Investigator:||Xiaozhong Chen, MD||Zhejiang Cancer Hospital|