Overview

This trial is active, not recruiting.

Condition nasopharyngeal carcinoma
Treatments cisplatin,fluorouracil, cisplatin
Phase phase 3
Sponsor Sun Yat-sen University
Collaborator Fudan University
Start date June 2006
End date March 2015
Trial size 506 participants
Trial identifier NCT00677118, YP2008004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Concurrent chemoradiotherapy plus adjuvant chemotherapy
cisplatin,fluorouracil Cisplatin and fluorouracil
Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then 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.
(Active Comparator)
Concurrent chemoradiotherapy
cisplatin Cisplatin
Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy.

Primary Outcomes

Measure
Failure-free survival
time frame: 2-yr

Secondary Outcomes

Measure
Overall survival, distant failure-free survival and locoregional failure-free survival
time frame: 2-yr

Eligibility Criteria

Male or female participants from 18 years up to 69 years old.

Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type) 2. Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system) 3. No evidence of distant metastasis (M0) 4. Performance status: KPS ≥70 5. With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal) 6. Renal: creatinine clearance ≥60ml/min 7. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL 8. Written informed consent Exclusion Criteria: 1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 2. Age ≥70 or <18 3. With a history of renal disease 4. Prior malignancy 5. Previous chemotherapy or radiotherapy 6. Patient is pregnant or lactating 7. Unstable cardiac disease requiring treatment. 8. Emotion disturbance

Additional Information

Official title A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.