Nasopharyngeal Carcinoma
Conditions
Keywords
nasopharyngeal carcinoma, neoadjuvant chemotherapy, concurrent chemotherapy, randomized controlled clinical trials
Brief 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.
Interventions
DRUGneoadjuvant 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.
Sponsors
Guangdong Provincial People's Hospital
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Affiliated Cancer Hospital of Shantou University Medical College
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO II or III * Original clinical stage must be T4 or N2-3 （UICC 2002） * Male and no pregnant female * Age between 18-60 * WBC ≥4,000/mm3 and PLT ≥ 100,000/mm3 * With normal liver function test (ALT、AST≤2.5×ULN) * With normal renal function test (Creatinine ≤ 1.5×ULN) * Performance status scale ECOG grade 0，1 * Without radiotherapy or chemotherapy * Patients must give signed informed consent
Exclusion criteria
* Patients have evidence of relapse or distant metastasis * The presence of uncontrolled life-threatening illness * Receiving other ways of anti-cancer therapy * Receiving radiotherapy or chemotherapy * Investigator consider the patients can't finish the whole study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| distant metastasis free survival,disease free survival | 5-Yr |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 5-Yr |
Countries
China
Contacts
Primary ContactSumei Cao, Ph. D.
Outcome results
None listed