A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Status:
Unknown status
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University Affiliated Cancer Hospital of Shantou University Medical College Cancer Center of Guangzhou Medical University Cancer Hospital of Shantou University Guangdong General Hospital Guangdong Provincial People's Hospital