A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 506
- Locations
- 1
- Primary Endpoint
- Failure-free survival
Study Overview
Brief Summary
The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.
Detailed Description
Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Patients are stratified according to the treatment centers. The primary end point was failure-free survival (FFS). Secondary end points included overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates after treatments, toxic effects and treatment compliance. All efficacy analyses were conducted in the intention-to-treat population; the safety population included only patients who received their randomly assigned treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type)
- •Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system)
- •No evidence of distant metastasis (M0)
- •Performance status: KPS ≥70
- •With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal)
- •Renal: creatinine clearance ≥60ml/min
- •Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL
- •Written informed consent
Exclusion Criteria
- •WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- •Age ≥70 or <18
- •With a history of renal disease
- •Prior malignancy
- •Previous chemotherapy or radiotherapy
- •Patient is pregnant or lactating
- •Unstable cardiac disease requiring treatment.
- •Emotion disturbance
Arms & Interventions
Concurrent and adjuvant
Concurrent chemoradiotherapy plus adjuvant chemotherapy
Intervention: Cisplatin,fluorouracil (Drug)
Concurrent
Concurrent chemoradiotherapy
Intervention: Cisplatin (Drug)
Outcomes
Primary Outcomes
Failure-free survival
Time Frame: 2-yr
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
Secondary Outcomes
- Overall survival, distant failure-free survival and locoregional failure-free survival(2-yr)