NCT00955240终止2 期
Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- UNICANCER
- 入组人数
- 16
- 试验地点
- 20
- 主要终点
- Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the objective response (complete and partial) 8 weeks after completion of study treatment comprising radiotherapy, chemotherapy (fluorouracil and cisplatin), and cetuximab followed by additional radiotherapy in patients with locally advanced anal cancer.
Secondary
- Evaluate colostomy-free survival.
- Evaluate the local control rate (objective response and stabilization) at 8 weeks.
- Evaluate relapse-free survival at 5 years.
- Evaluate the intermediate objective response at the end of week 5 of radiotherapy.
- Evaluate overall survival at 5 years.
- Evaluate the duration of response.
- Evaluate acute toxicities according to CTCAE v3.0.
- Evaluate late toxicities at 5 years according to CTCAE v3.0.
- Study the tumor markers associated with response (survival without relapse) and toxicity.
- Study the genotypes of Fc-receptor immunoglobulins (FCGR2A and FCGR3) and their association with skin toxicity, objective survival, and relapse-free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed anal cancer
- •Squamous cell disease
- •Locally advanced, non-metastatic disease
- •One of the following clinical TNM stages:
- •T2, N0, M0 (largest diameter ≥ 3 cm)
- •T3-T4, N0, M0
- •Any T, N1-N3, M0
- •No undifferentiated small cell carcinoma or adenocarcinoma
- •Measurable disease according to RECIST criteria
- •Undergone endorectal ultrasound or MRI to evaluate the primary tumor
- •Undergone thoraco-abdomino-pelvic scan to evaluate tumor extension
- •Disease suitable to receive radiotherapy and chemotherapy
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Leukocytes ≥ 4,000/mm^3
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Creatinine clearance > 60 mL/min
- •ALT and AST ≤ 5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Total bilirubin ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •No history of cancer within the past 8 years except for in situ cervical cancer or previously treated basal cell carcinoma of the skin
- •No contraindications to any component of study therapy
- •No serious uncontrolled illness
- •No symptomatic grade 1 angina pectoris or angina pectoris ≥ grade 2
- •No congestive heart failure
- •No peripheral sensory neuropathy
- •No uncontrolled diabetes
- •No HIV positivity
- •No geographical, social, or psychological situations that preclude medical follow up
- •Affiliated with a social security system
- •No patient deprived of liberty or under trusteeship
- •PRIOR CONCURRENT THERAPY:
- •Patients with a diverting colostomy are eligible
- •No prior excision of this tumor
- •No prior chemotherapy or radiotherapy for the treatment of this cancer or any other history of radiotherapy or pelvic brachytherapy
- •No concurrent coumarin anticoagulants, phenytoin, sorivudine or brivudine, antacids, or allopurinol
- •Not registered in another clinical trial with an experimental drug
排除标准
- 未提供
结局指标
主要结局
Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment
次要结局
- Survival rate at 3 and 5 years
- Colostomy-free survival at 3 and 5 years
- Duration of objective response
研究者
研究点 (20)
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