Randomized Phase Ⅱ Trial of Induction Chemotherapy Using Gemcitabine and Cisplatin in Concurrence With Intensity-modulated Radiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Cisplatin
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- First People's Hospital of Foshan
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Failure-free survival
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy using gemcitabine and cisplatin in NPC patients.
Detailed Description
Patients presented with non-keratinizing NPC and stage Ⅲ-Ⅳb T3-4N1M0/TxN2-3M0 are randomly assigned to receive induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical Intensity modulated radiation therapy (Trilogy, Varian), and cisplatin (40mg/m2) every weeks for six cycles during radiotherapy. Radiation is delivered to GTV at 70 Gy in 30 fractions, CTV1 at at 60 Gy in 30 fractions and CTV2 at 54 Gy in 30 fractions. Patients in the investigational arm receive gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy. The primary end point is response rates after radiotherapy, failure-free survival (FFS) and toxic effects and treatment compliance. Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS). All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.
Investigators
Tao Xu
Foshan head and neck group
First People's Hospital of Foshan
Eligibility Criteria
Inclusion Criteria
- •Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
- •Karnofsky scale (KPS) \>
- •Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N
- •Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- •Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- •Adequate renal function: creatinine clearance ≥60 ml/min.
- •Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria
- •WHO Type keratinizing squamous cell carcinoma.
- •Age \>60 years or \<18 years.
- •Treatment with palliative intent.
- •Pregnancy or lactation.
- •Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- •Any severe intercurrent disease including unstable cardiac disease, chronic hepatitis, renal disease, diabetes with poor control, and emotional disturbance.
Arms & Interventions
Concurrent chemoradiotherapy
Patients receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy
Intervention: Cisplatin
Outcomes
Primary Outcomes
Failure-free survival
Time Frame: 3-year
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
Secondary Outcomes
- Overall survival(3-year)
- Locoregional failure-free survival(3-year)
- Distant failure-free survival(3-year)
- The initial response rates after treatments(16 weeks after completion of radiotherapy)