Induction Chemotherapy of TPX in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma

Phase 3

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: IMRT; Drug: Docetaxel; Drug: Cisplatin 2; Drug: Cisplatin 1; Drug: Xeloda

• Registration Number: NCT02786641
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The investigators aim to evaluate the efficiency and toxicities of induction chemotherapy of docetaxel, cisplatin and xeloda in nomogram-predicted high risk locoregionally advanced nasopharyngeal carcinoma.

Detailed Description

All eligible patients receive intensity-modulated radiotherapy (IMRT) with a total dose of 68 Gy or higher in 33 fractions to the primary tumor. Nomogram-predicted low risk patients (Group A) receive concurrent chemotherapy, while nomogram-predicted high risk patients are randomized to receive concurrent chemotherapy (Group B) or induction chemotherapy followed by concurrent chemotherapy (Group C). Induction chemotherapy consists of docetaxel 65 mg/m², D1, cisplatin 75 mg/m², D1 and Xeloda 2000mg/m², D1-14 every 3 weeks for 3 cycles. Concurrent chemotherapy consists of cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is failure-free survival (FFS). Secondary end points include overall survival (OS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS) and the incidence of grade 3 or higher acute toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-05-26
• Last Update Submitted: 2016-05-26
• Study First Posted: 2016-06-01
• Last Update Posted: 2016-06-01
• Study Start: 2016-08
• Primary Completion: 2018-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

• Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
• Tumor staged as III-IVb (the 2010 UICC/AJCC staging system).
• Karnofsky scale (KPS) ≥ 70.
• Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L.
• Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN.
• Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.
• Patients must give written informed consent.

Exclusion Criteria

• Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
• Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
• History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume).
• Prior radiotherapy, 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.
• Deficient in dihydropyrimidine dehydrogenase

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group C	Xeloda	high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy
Group B	IMRT	high risk NPC treated with concurrent chemoradiotherapy
Group C	IMRT	high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy
Group A	IMRT	low risk NPC treated with concurrent chemoradiotherapy
Group A	Cisplatin 2	low risk NPC treated with concurrent chemoradiotherapy
Group B	Cisplatin 2	high risk NPC treated with concurrent chemoradiotherapy
Group C	Cisplatin 1	high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy
Group C	Cisplatin 2	high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy
Group C	Docetaxel	high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
FFS	2 years

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China