Clinical trial NCT02143388: Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Local Advanced High Risk Nasopharyngeal Carcinoma
Keywords: Local advanced
high risk
nasopharyngeal carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Jiangxi Provincial Cancer Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: National Cancer Centre, Singapore
First posted: 2014-05-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Failure free survival
timeFrame: 3-year
Secondary outcomes:
measure: Acute Toxicity
timeFrame: 18 months
Other outcomes:
measure: Locoregional relapse free survival
timeFrame: 3-year
measure: Distance metastasis free survival
timeFrame: 3-year
measure: Overall survival rate
timeFrame: 3-year
measure: Late Toxicity
timeFrame: 3 years
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: zhao chong, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miao J, Wang L, Tan SH, Li JG, Yi J, Ong EHW, Tan LLY, Zhang Y, Gong X, Chen Q, Xiang YQ, Chen MY, Guo Y, Lv X, Xia WX, Tang L, Deng X, Guo X, Han F, Mai HQ, Chua MLK, Zhao C. Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Oct 13;8(12):1776-85. doi: 10.1001/jamaoncol.2022.4656. Online ahead of print.