Multicentre，A Phase II/III Randomized Study of Adjuvant Anti-Angiogenesis Therapy for Patients of High-Risk Oral Cavity Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 150
- 主要终点
- The primary endpoint is the tumor-free survival that is defined as the duration between the dates of operation and the date of disease recurrence.
研究概览
简要总结
Objectives:
- To study the effect of anti-angiogenesis therapy on reducing the recurrence of high-risk oral cavity cancer patients after curative local treatment.
- To study the toxicity and compliance of post-operative anti-angiogenesis therapy
Study design:
This is a multi-center randomized controlled phase II/III two-stage study.
Study endpoints:
The primary endpoint is the tumor-free survival (primary and second primary malignancies) and the primary analysis is to compare the tumor-free survival between groups.
详细描述
Type and number of patients:
Patients with resectable oral cancer of clinical stage N2, 3 or skin-involved T4 will be enrolled.
Sample size at the first stage is 64 patients per group and the total sample size at the end of the second stage is 192 patients per group, assuming that the accrual rate/hazard rate = 1.33, an α=0.05 and power of 0.8 (Hypotheses: H0:θ ≦ 1.0 and Ha: θ ≧ 1.33)
Treatment schedule:
Group A：standard postoperative concurrent chemoradiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proved oral cavity squamous cell carcinoma (buccal and mobile tongue).
- •Clinical stage T4a with skin involvement or resectable N2-3 by UICC/AJCC 1997 staging system.(24)
- •Curative-intent operation feasible and arranged.
- •Eastern Cooperative Oncology Group performance status ≦
- •A leukocyte count ≧3750/μL, Hb ≧10 g/dL, and a platelet count ≧100,000/μL.
- •A serum bilirubin level < 1.5 UNL (upper normal limit), serum creatinine level < 1.5 UNL or creatinine clearance > 60 mL/min.
- •Age less than 70 years old
- •Informed consent signed.
排除标准
- •Evidence of distant metastatic.
- •Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin.
- •Presence of uncontrolled hypertension, poorly controlled heart failure.
- •Presence of active infection.
- •Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies.
- •Women who test positive for pregnancy. Note: Patients received neck lymph node biopsy will be eligible and the stage will be given according to the preoperative status.
研究组 & 干预措施
Thalidomide, Celebrex
Adjuvant anti-angiogenesis therapy
干预措施: Thalidomide, Celebrex (Drug)
Cyclophosphamide, Dexamethasone
Adjuvant anti-angiogenesis therapy
干预措施: Cyclophosphamide, Dexamethasone (Drug)
结局指标
主要结局
The primary endpoint is the tumor-free survival that is defined as the duration between the dates of operation and the date of disease recurrence.
时间窗: 7 years
次要结局
- Physical examinations, lab abnormality and other toxicities graded by the NCI Common Toxicity Criteria will be examined to evaluate safety profiles of the study treatments.(7 years)