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

Zhao Chong

Status and phase: Completed; Phase 3

Conditions: Local Advanced High Risk Nasopharyngeal Carcinoma

Treatments: Drug: IMRT combine with cisplatin concurrent chemotherapy; Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02143388

CCRT-AC-LAHR-NPC

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Concurrent chemoradiation + adjuvant chemotherapy

Experimental group

Description:

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Treatment:

Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Concurrent chemoradiation

Active Comparator group

Description:

IMRT combine with cisplatin concurrent chemotherapy

Treatment:

Drug: IMRT combine with cisplatin concurrent chemotherapy