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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

low risk NPC treated with concurrent chemoradiotherapy

Group Type ACTIVE_COMPARATOR

IMRT

Intervention Type RADIATION

IMRT for all patients

Cisplatin 2

Intervention Type DRUG

Cisplatin 100mg/m2 in concurrent chemotherapy

Group B

high risk NPC treated with concurrent chemoradiotherapy

Group Type ACTIVE_COMPARATOR

IMRT

Intervention Type RADIATION

IMRT for all patients

Cisplatin 2

Intervention Type DRUG

Cisplatin 100mg/m2 in concurrent chemotherapy

Group C

high risk NPC treated with induction chemotherapy plus concurrent chemoradiotherapy

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

Docetaxel 65mg/m2 in induction chemotherapy

Cisplatin 1

Intervention Type DRUG

Cisplatin 75mg/m2 in induction chemotherapy

Xeloda

Intervention Type DRUG

Xeloda 2000mg/m2 D1-14 in induction chemotherapy

IMRT

Intervention Type RADIATION

IMRT for all patients

Cisplatin 2

Intervention Type DRUG

Cisplatin 100mg/m2 in concurrent chemotherapy

Interventions

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Docetaxel

Docetaxel 65mg/m2 in induction chemotherapy

Intervention Type DRUG

Cisplatin 1

Cisplatin 75mg/m2 in induction chemotherapy

Intervention Type DRUG

Xeloda

Xeloda 2000mg/m2 D1-14 in induction chemotherapy

Intervention Type DRUG

IMRT

IMRT for all patients

Intervention Type RADIATION

Cisplatin 2

Cisplatin 100mg/m2 in concurrent chemotherapy

Intervention Type DRUG

Other Intervention Names

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T P X DDP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No