Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma (ESNCCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|Principal Investigator:||Xiaozhong Chen, MD||Zhejiang Cancer Hospital|