A Multicenter Trial Comparing Neoadjuvant Chemotherapy Followed by CCRT v.s. CCRT Alone in Locoregionally Advanced Nasopharyngeal Carcinoma
Phase 3
18 Years
60 Years
18 Years
60 Years
Open (Enrolling)
Both
Nasopharyngeal Carcinoma
Both
Nasopharyngeal Carcinoma
Trial Information
A Multicenter Trial Comparing Neoadjuvant Chemotherapy Followed by CCRT v.s. CCRT Alone in Locoregionally Advanced Nasopharyngeal Carcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
distant metastasis free survival,disease free survival
Outcome Time Frame:
5-Yr
Safety Issue:
Yes
Principal Investigator
Minghuang Hong, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sun Yet sen Cancer Center, China
Authority:
China: Ministry of Health
Study ID:
2007047
NCT ID:
NCT00705627
Start Date:
June 2008
Completion Date:
June 2017
Related Keywords:
- Nasopharyngeal Carcinoma
- nasopharyngeal carcinoma
- neoadjuvant chemotherapy
- concurrent chemotherapy
- randomized controlled clinical trials
- Carcinoma
- Nasopharyngeal Neoplasms
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