Nasopharyngeal Carcinoma
Conditions
Keywords
Cisplatin, neoadjuvant chemotherapy, intensity-modulated radiation therapy, concurrent chemoradiotherapy
Brief summary
Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.
Detailed description
The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.
Interventions
DRUGInductive chemotherapy + concurrent cisplatin and IMRT
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2，on day 1) repeated every week for 6 cycles during radiotherapy.
DRUGInductive chemotherapy + IMRT
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type). * A Karnofsky performance status of at least 80; * Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N3. * Adequate marrow: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/l. * Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN. * Adequate renal function: a creatinine clearance rate of at least 60 mL/min. * Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion criteria
* WHO Type keratinizing squamous cell carcinoma. * Age \>65 years or \<18 years. * Distant metastasis, * Treatment with palliative intent. * Pregnancy or lactation. * a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy. * history of renal disease, unstable cardiac disease requiring treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distant failure-free survival | 3-year | The latency to the first remote failure |
| Overall survival | 3-year | Overall survival is calculated from randomization to death from any cause. |
| Failure-free survival | 3-year | Failure-free survival is calculated from the date of randomization to the date of the first failure at any site. |
| Locoregional failure-free survival | 3-year | the latency to the first local failure |
Secondary
| Measure | Time frame |
|---|---|
| Difference in the complete response rates between the two treatment arms | 12 weeks after the completion of therapy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rates of toxicity | 3-years | Rates of toxicity will also be compared. Rates will be compared by the chi-square test.The Chemotherapy toxicity include thrombocytopenia, leukocytopenia , anemia, granulocytopenia,damage to hepatic function, damage to renal function,constipation, diarrhea,vomiting and rash. The radiotherapy toxicities include mucositis, radiation dermatitis,dysphagia, xerostomia, skin fibrosis, trismus, hearing loss ane cranial neuropathy. |
Countries
China
Contacts
Primary ContactJanjun Li, M.D.
Backup ContactLizhi Liu, M.D.
Outcome results
None listed