Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Docetaxel, cisplatin and fluorouracil; Radiation: Concurrent chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01245959

YP2010171

Details and patient eligibility

About

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.

Full 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.

Enrollment: 476 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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476 participants in 2 patient groups

Induction chemotherapy and concurrent chemoradiotherapy

Experimental group

Description:

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.

Treatment:

Radiation: Concurrent chemoradiotherapy

Drug: Docetaxel, cisplatin and fluorouracil

Concurrent chemoradiotherapy

Active Comparator group

Description:

Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Treatment:

Radiation: Concurrent chemoradiotherapy