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

Local Advanced High Risk Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143388
• Other study ID #: CCRT-AC-LAHR-NPC
• Status: Completed
• Phase: Phase 3
• Start date: March 31, 2014
• Est. completion date: August 5, 2022

Study information

• Verified date: August 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 5, 2022
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Local Advanced High Risk Nasopharyngeal Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Zhao Chong	Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Jiangxi Provincial Cancer Hospital, National Cancer Centre, Singapore

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Locoregional relapse free survival	Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.	3-year
Other	Distance metastasis free survival	Defined as the time from date of recruitment to documented distant metastatic recurrence or death from any cause.	3-year
Other	Overall survival rate	Defined as the time from date of recruitment to death from any cause.	3-year
Other	Late Toxicity	To evaluate the late toxicity with the RTOG/EORTC criterion when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.	3 years
Primary	Failure free survival	Defined as the time from date of recruitment to documented relapse or death from any cause.	3-year
Secondary	Acute Toxicity	To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.	18 months

External Links

•   Home Page of Cancer Center, Sun Yat-sen University