Local Advanced High Risk Nasopharyngeal Carcinoma
Conditions
Keywords
Local advanced, High Risk, Nasopharyngeal Carcinoma
Brief summary
This is a randomized,controlled,prospective phase III 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 Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.
Interventions
Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT.
Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles at 4 weeks later after RT.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III) * Clinical stage III\~IVb(UICC/AJCC 7th) * No distant metastasis * Karnofsky Performance Status Scale≥70 * WBC count ≥ 4×109/L, neutrophil differential count≥ 1.5×109/L, Hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L * ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN, Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min * Sign the informed consent.
Exclusion criteria
* Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas * Younger than 18 years old or older than 70 years old * Are receiving other drugs treanment * kidney disease * Have suffered from other tumor or now suffering from other tumor * Have recieved chemotherapy or radiotherapy * Pregnancy or lactation * unstable heart disease need timely treatment * Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distant metastasis-free survival | Five year | Defined as the time from date of recruitment to documented distant metastasis or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free survival | Five year | Defined as the time from date of recruitment to documented relapse or death from any cause. |
| Locoregional relapse-free survival | Five year | Defined as the time from date of recruitment to documented locoregional relapse or death from any cause. |
| Overall survival | Five year | Defined as the time from date of recruitment to death from any cause. |
| Acute toxicity | three months after corresponding treatment | Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0) for chemotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities. |
| Late toxicity | Five year | Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORzhao chong, M.D
Sun Yat-Sen University Cancer Center
Outcome results
None listed