Title
A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma
Phase
Phase 3Lead Sponsor
China Three Gorges University, Yichang, ChinaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Nasopharyngeal NeoplasmsIntervention/Treatment
endostatin cisplatin ...Study Participants
75Among all the head and neck tumors, nasopharyngeal carcinoma (NPC) has a high tendency of recurrence and metastasis. For the advanced NPC patients, chemoradiotherapy is the main way of treatment. Currently, chemotherapy with cisplatin (DDP) combines with 5-fluorouracil (5-FU) is the classic front line therapy for NPC. However, the abnormal richness of angiogenesis of tumor and blood supply in tissue caused by radiation therapy often decrease the effects of radiochemotherapy. Human recombinant vascular endothelial inhibitor (endostar) can improve the sensitivity to chemoradiation via selectively inhibiting the migration of endothelial cells and the formation of tumor vessels. Moreover, it would induce vascular remodeling and normalization of the tumor vasculature, which will effectively aid the delivery of oxygen and anticancer drugs. In sum, antiangiogenesis in combination with chemoradiotherapy will be a promising way of treatment for NPC. In this study, the first-treated patients with NPC (stage Ⅲ or Ⅳa) confirmed by pathology, and patients with recurrent and metastatic NPC will be randomly assigned to two groups (1:1): a trial group (DDP, 5-FU, endostar and sequential intensity modulated radiation therapy (IMRT)), and a control group (DDP，5-FU and sequential IMRT). Evaluations will be developed including progression-free survival (PFS), Overall response rate（ORR）, overall survival (OS), adverse effects rate and quality of life. This research will provide more evidences of evidence-based medicine for the safety and tolerability of endostar and the clinical application of endostar in NPC treatment.
patient first receive one periodicity chemotherapy(DDP (25mg/m2/d; ivgtt; d1～3)+5-FU (600mg/m2/d; ivgtt; d1～5)+endostar (150mg/5d; civ; d1～5)), then given IMRT (5 times per week, 6 weeks). After rest 4 weeks, continue to give the chemotherapy (21 days for a periodicity, 3 periodicities).
patient first receive one periodicity chemotherapy(DDP (25mg/m2/d; ivgtt; d1～3)+5-FU (600mg/m2/d; ivgtt; d1～5)), then given IMRT (5 times per week, 6 weeks). After rest 4 weeks, continue to give the chemotherapy (21 days for a periodicity, 3 periodicities).
Inclusion Criteria: Age from 18 to 70 ears ; Eastern Cooperative Oncology Group performance status of 0-1; diagnosed with first-treated NPC (Ⅲ/Ⅳa stage) confirmed by pathology; ecurrent and metastatic NPC with indication of chemoradiotherapy; one measurable lesion at least (according to the RECIST guidelines, the lesion iameter≥20 mm with MRI); life expectancy of ≥ 12 weeks; adequate hematologic, renal, cardiac and liver function; hemameba≥4.0×109/L; neutrophil≥2.0×109/L; platelet≥100×109/L; hemoglobin≥95g/L; Serum bilirubin, ALT and AST ≤1.5 times of maximum criteria; sufficiently understand this study situation and signed the informed consent. Exclusion Criteria: allergy or intolerance to study drugs; receiving other anti-cancer therapy; uncontrolled central nervous system lesions; dysfunction of important organs； history of cardiovascular disease(including congestive heart-failure, uncontrolled arrhythmia, angina pectoris which require long-term drug treatment, lular heart disease, myocardial infarction and resistant hypertension); pregnancy or lactation in women; protracted Infective wound; history of mental illness which is not easy controlled.
