Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2022-08-05

Brief Summary

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This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.

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Detailed Description

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Conditions

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Local Advanced High Risk Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concurrent chemoradiation + adjuvant chemotherapy

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Group Type EXPERIMENTAL

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Intervention Type DRUG

Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.

Concurrent chemoradiation

IMRT combine with cisplatin concurrent chemotherapy

Group Type ACTIVE_COMPARATOR

IMRT combine with cisplatin concurrent chemotherapy

Intervention Type DRUG

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.

Interventions

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IMRT combine with cisplatin concurrent chemotherapy

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.

Intervention Type DRUG

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
* Clinical stage III\~IVb(UICC 7th)
* Meet at least one factor below :1 primary tumor SUVmax\>10 in 18F-FDG PET/CT;2 primary tumor volume\>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter\>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA\>2×10E4 copy/l
* Range from 18～70 years old
* WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
* ALT or AST \< 2.5×ULN、bilirubin \< 1.5×ULN
* OSerum creatinine \< 1.5×ULN

Exclusion Criteria

* Central nervous system metastases
* Suitable for local treatment
* Uncontrolled seizure disorder or other serious neurologic disease
* Clinically significant cardiac or respiratory disease
* Drug or alcohol addition
* Do not have full capacity for civil acts
* Severe complication, active infection
* Concurrent immunotherapy or hormone therapy for other diseases
* Pregnancy or lactation

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No