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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02786641

Collaborator

(none)

235

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Drug: Docetaxel Drug: Cisplatin 1 Drug: Xeloda Radiation: IMRT Drug: Cisplatin 2	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

235 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Induction Chemotherapy of Docetaxel, Cisplatin and Xeloda in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A low risk NPC treated with concurrent chemoradiotherapy	Radiation: IMRT IMRT for all patients Drug: Cisplatin 2 Cisplatin 100mg/m2 in concurrent chemotherapy Other Names: DDP
Active Comparator: Group B high risk NPC treated with concurrent chemoradiotherapy	Radiation: IMRT IMRT for all patients Drug: Cisplatin 2 Cisplatin 100mg/m2 in concurrent chemotherapy Other Names: DDP
Experimental: Group C high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy	Drug: Docetaxel Docetaxel 65mg/m2 in induction chemotherapy Other Names: T Drug: Cisplatin 1 Cisplatin 75mg/m2 in induction chemotherapy Other Names: P Drug: Xeloda Xeloda 2000mg/m2 D1-14 in induction chemotherapy Other Names: X Radiation: IMRT IMRT for all patients Drug: Cisplatin 2 Cisplatin 100mg/m2 in concurrent chemotherapy Other Names: DDP

Arm

Intervention/Treatment

Active Comparator: Group A

low risk NPC treated with concurrent chemoradiotherapy

Radiation: IMRT

IMRT for all patients

Drug: Cisplatin 2

Cisplatin 100mg/m2 in concurrent chemotherapy

Other Names:

DDP

Active Comparator: Group B

high risk NPC treated with concurrent chemoradiotherapy

Radiation: IMRT

IMRT for all patients

Drug: Cisplatin 2

Cisplatin 100mg/m2 in concurrent chemotherapy

Other Names:

DDP

Experimental: Group C

high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy

Drug: Docetaxel

Docetaxel 65mg/m2 in induction chemotherapy

Other Names:

Drug: Cisplatin 1

Cisplatin 75mg/m2 in induction chemotherapy

Other Names:

Drug: Xeloda

Xeloda 2000mg/m2 D1-14 in induction chemotherapy

Other Names:

Radiation: IMRT

IMRT for all patients

Drug: Cisplatin 2

Cisplatin 100mg/m2 in concurrent chemotherapy

Other Names:

DDP

Outcome Measures

Primary Outcome Measures

FFS [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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