Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer
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
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.
研究概览
详细说明
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.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV on days 0, 7, 14, 21, 28, and 35; fluorouracil IV on days 7-10 and 35-38; and cisplatin IV over 2 hours on days 7 and 35. Beginning on day 7, patients also undergo radiotherapy 5 days a week for 5 weeks (weeks 2-6). Two weeks after finishing this treatment, patients undergo additional radiotherapy* 5 days a week for 2 weeks (weeks 9 and 10).
NOTE: *Some patients may undergo brachytherapy.
Blood and tissue samples are collected for further analysis.
After completion of study treatment, patients are followed up for 4 years.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Bordeaux、法国、33076
- Institut Bergonié
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Brest、法国、29609
- CHU Hopital A. Morvan
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Caen、法国、14076
- Centre Regional Francois Baclesse
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La Roche Sur Yon、法国、F-85025
- Centre Hospitalier departemental
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Lille、法国、59020
- Centre Oscar Lambret
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Limoges、法国、87042
- Centre Hospital Regional Universitaire de Limoges
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Lyon、法国、69373
- Centre Léon Bérard
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Montpellier、法国、34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Nantes-Saint Herblain、法国、44805
- Centre Regional Rene Gauducheau
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Nice、法国、06189
- Centre Antoine Lacassagne
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Paris、法国、75970
- Hôpital Tenon
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Paris、法国、75475
- Hopital Saint-Louis
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Paris、法国、75248
- Institut Curie Hopital
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Pierre Benite、法国、69495
- Centre Hospitalier Lyon Sud
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Rouen、法国、76031
- Hôpital Charles Nicolle
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Saint-Gregoire、法国、35768
- Centre Hospitalier Prive Saint-Gregoire
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Toulouse、法国、31078
- Clinique du Parc
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Toulouse、法国、31300
- Groupe Oncorad Garonne
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Vandoeuvre-les-Nancy、法国、54511
- Centre Alexis Vautrin
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Villejuif、法国、F-94805
- Institut Gustave Roussy
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
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Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment
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次要结果测量
结果测量 |
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客观反应的持续时间
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Survival rate at 3 and 5 years
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Colostomy-free survival at 3 and 5 years
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合作者和调查者
赞助
调查人员
- 首席研究员：Eric Deutsch, MD、Gustave Roussy, Cancer Campus, Grand Paris
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CDR0000642638
- FRE-FNCLCC-ACCORD-16-0708 (其他标识符：LNCLCC)
- EU-20941 (其他标识符：European union)
- 2007-007029-38 (EudraCT编号)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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