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

Phase 3

Completed

• Conditions: Local Advanced High Risk Nasopharyngeal Carcinoma
• Interventions: Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy; Drug: IMRT combine with cisplatin concurrent chemotherapy

• Registration Number: NCT02143388
• Lead Sponsor: Zhao Chong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-31
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-18
• Study First Posted: 2014-05-21
• Primary Completion: 2018-07-27
• Status Verified: 2022-08
• Study Completion: 2022-08-05
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurrent chemoradiation + adjuvant chemotherapy	IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy	IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
Concurrent chemoradiation	IMRT combine with cisplatin concurrent chemotherapy	IMRT combine with cisplatin concurrent chemotherapy

Primary Outcome Measures

Name	Time	Method
Failure free survival	3-year	Defined as the time from date of recruitment to documented relapse or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Acute Toxicity	18 months	To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China