Clinical trial NCT00705627: A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Official title: A Multicenter Trial Comparing Neoadjuvant Chemotherapy Followed by CCRT v.s. CCRT Alone in Locoregionally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma
neoadjuvant chemotherapy
concurrent chemotherapy
randomized controlled clinical trials
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Affiliated Cancer Hospital of Shantou University Medical College
First posted: 2008-06-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: distant metastasis free survival,disease free survival
timeFrame: 5-Yr
Secondary outcomes:
measure: overall survival
timeFrame: 5-Yr
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yet sen Cancer Center, China
name: Minghuang Hong, MD
role: STUDY_CHAIR
References: