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

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Cisplatin 2; Drug: Docetaxel; Radiation: IMRT; Drug: Cisplatin 1; Drug: Xeloda

Study type: Interventional

Funder types: Other

Identifiers

NCT02786641

2016-FXY-012-Dept. of RT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 235 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

235 participants in 3 patient groups

Group A

Active Comparator group

Description:

low risk NPC treated with concurrent chemoradiotherapy

Treatment:

Radiation: IMRT

Drug: Cisplatin 2

Group B

Active Comparator group

Description:

high risk NPC treated with concurrent chemoradiotherapy

Treatment:

Radiation: IMRT

Drug: Cisplatin 2

Group C

Experimental group

Description:

high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy

Treatment:

Drug: Xeloda

Radiation: IMRT

Drug: Cisplatin 1

Drug: Docetaxel

Drug: Cisplatin 2