Overview

This trial is active, not recruiting.

Condition nasopharyngeal carcinoma
Treatments docetaxel, cisplatin and fluorouracil, concurrent chemoradiotherapy
Phase phase 3
Sponsor Sun Yat-sen University
Collaborator Fudan University
Start date January 2011
End date April 2016
Trial size 476 participants
Trial identifier NCT01245959, YP2010171

Summary

The purpose of this study is to compare induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy in 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)
Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
docetaxel, cisplatin and fluorouracil TPF induction chemotherapy
Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
concurrent chemoradiotherapy Radical radiotherapy and concurrent cisplatin
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
(Active Comparator)
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
concurrent chemoradiotherapy Radical radiotherapy and concurrent cisplatin
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Primary Outcomes

Measure
Failure-free survival
time frame: 3-year

Secondary Outcomes

Measure
Overall survival
time frame: 3-year
Locoregional failure-free survival
time frame: 3-year
Distant failure-free survival
time frame: 3-year
The initial response rates after treatments
time frame: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy
Toxic effects
time frame: During and after treatment

Eligibility Criteria

Male or female participants from 18 years up to 59 years old.

Inclusion Criteria: - Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). - Tumor staged as T3-4N1/N2-3 (according to the 7th American Joint Commission on Cancer edition). - No evidence of distant metastasis (M0). - Satisfactory performance status: Karnofsky scale (KPS) > 70. - 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 or basaloid squamous cell carcinoma. - Age ≥60 years or <18 years. - Treatment with palliative intent. - Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. - Pregnancy or lactation. - History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). - Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. - Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Additional Information

Official title Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy 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 induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Patients in the investigational arm receive docetaxel(60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy. Patients are stratified according to the treatment centers and stage. The primary end point is failure-free survival (FFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.