Local Advanced High Risk Nasopharyngeal Carcinoma
Conditions
Keywords
Local advanced, high risk, nasopharyngeal carcinoma
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.
Interventions
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.
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.
Sponsors
Jiangxi Provincial Cancer Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
National Cancer Centre, Singapore
Zhao Chong
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure free survival | 3-year | Defined as the time from date of recruitment to documented relapse or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Locoregional relapse free survival | 3-year | Defined as the time from date of recruitment to documented locoregional relapse or death from any cause. |
| Distance metastasis free survival | 3-year | Defined as the time from date of recruitment to documented distant metastatic recurrence or death from any cause. |
| Overall survival rate | 3-year | Defined as the time from date of recruitment to death from any cause. |
| Late Toxicity | 3 years | To evaluate the late toxicity with the RTOG/EORTC criterion when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used. |
Countries
China
Outcome results
None listed