Brief Title
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
distant metastasis free survival,disease free survival
Secondary Outcome
overall survival
Condition
Nasopharyngeal Carcinoma
Intervention
neoadjuvant chemotherapy plus concurrent chemoradiotherapy
Study Arms / Comparison Groups
B
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
400
Start Date
June 2008
Completion Date
June 2017
Primary Completion Date
February 2015
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
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Minghuang Hong, MD, 86-20-8734-5685, [email protected]/sysu.edu.cn
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT00705627
Organization ID
2007047
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Collaborators
Guangdong Provincial People's Hospital
Study Sponsor
Minghuang Hong, MD, Study Chair, Sun Yet sen Cancer Center, China
Verification Date
May 2014