A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
|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: NCT00705627|
Recruitment Status : Unknown
Verified May 2014 by Hong Ming-huang, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : June 26, 2008
Last Update Posted : May 28, 2014
Locoregionally advanced nasopharyngeal carcinoma (NPC)(stage III, IV in UICC 2002 Classification) can be divided into two groups according to the risk of metastasis: high-risk metastasis group (T4 or N2-3) and low-risk metastasis group (T3N0-1). In low-risk metastasis group, concurrent chemoradiotherapy (CCRT) might decrease local recurrence and distance metastasis, which benefits overall survival. On the other hand, neoadjuvant chemotherapy is also associated with lower distance metastasis of advanced stage NPC. Nevertheless, CCRT alone or neoadjuvant chemotherapy alone leads to unsatisfactory results regarding to distance metastasis in patients with high-risk metastasis group. In this case, it is utmost important to investigate the new treatment combining neoadjuvant chemotherapy plus CCRT in order to improve overall survival of locoregionally advanced NPC with high-risk metastasis.
In our study, in order to investigate the effect and adverse reaction of neoadjuvant chemotherapy plus CCRT on distance metastasis and locoregionally relapse, four hundred patients with high risk of distance metastasis will be randomly divided into two groups, comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of distance metastasis.
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Drug: neoadjuvant chemotherapy plus concurrent chemoradiotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Trial Comparing Neoadjuvant Chemotherapy Followed by CCRT v.s. CCRT Alone in Locoregionally Advanced Nasopharyngeal Carcinoma|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||June 2017|
Drug: cisplatin. Patients in the control arm received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.
Drug: neoadjuvant chemotherapy plus concurrent chemoradiotherapy
Drug: cisplatin,fluorouracil. Patients received cisplatin 80mg/m2 on day 1,fluorouracil 4000mg/m2 civ 120 hours every three weeks for two cycles, then received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.
Other Name: Neoadjuvant Chemotherapy Followed by CCRT
- distant metastasis free survival,disease free survival [ Time Frame: 5-Yr ]
- overall survival [ Time Frame: 5-Yr ]
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): NCT00705627
|Contact: Sumei Cao, Ph. D.||86-20-8734-5685||caosumei@mail/sysu.edu.cn|
|Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Sumei Cao, Ph. D 86-20-8734-5685 firstname.lastname@example.org|
|Principal Investigator: Minghuang Hong, MD|
|Study Chair:||Minghuang Hong, MD||Sun Yet sen Cancer Center, China|