Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer
Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known if fluorouracil plus radiation therapy is more effective with or without additional chemotherapy in treating anal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus radiation therapy with or without additional chemotherapy in treating patients who have primary anal cancer.
研究概览
详细说明
OBJECTIVES:
- Compare the response rates in patients with primary epidermoid anal cancer treated with radiotherapy and fluorouracil with either mitomycin or cisplatin and with or without maintenance therapy.
- Compare local control and prevention or delay of disease dissemination in patients treated with these regimens.
OUTLINE: This is randomized, open-label, multicenter study. Patients are randomized to one of four treatment arms.
All patients undergo radiotherapy daily 5 days a week for 5.5 weeks. All patients also receive fluorouracil IV continuously over days 1-4 and 29-32.
- Arm I: Patients receive mitomycin IV on day 1.
- Arm II: Patients receive cisplatin IV on days 1 and 29.
- Arm III: Patients receive mitomycin as in arm I and maintenance therapy comprising fluorouracil IV continuously over days 1-4 and cisplatin IV on day 1 beginning 4-8 weeks after completion of primary therapy and repeating once 3 weeks later.
- Arm IV: Patients receive cisplatin as in arm II and maintenance therapy as in arm III.
Patients are followed at 2 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this study.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Sheffield、英国、S1O 2SJ
- Cancer Research Centre at Weston Park Hospital
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England
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Harrow、England、英国、HA1 3UJ
- Northwick Park Hospital
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Ipswich、England、英国、IP4 5PD
- Ipswich Hospital
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Leeds、England、英国、LS16 6QB
- Cookridge Hospital
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London、England、英国、EC1A 7BE
- Saint Bartholomew's Hospital
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London、England、英国、NW1 2ND
- Cancer Research UK and University College London Cancer Trials Centre
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Middlesbrough、England、英国、TS4 3BW
- James Cook University Hospital
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Northwood、England、英国、HA6 2RN
- Mount Vernon Cancer Centre at Mount Vernon Hospital
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Nottingham、England、英国、NG5 1PB
- Nottingham City Hospital
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Sutton、England、英国、SM2 5PT
- Royal Marsden - Surrey
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Westcliff-On-Sea、England、英国、SS0 0RY
- Southend University Hospital NHS Foundation Trust
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Scotland
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Aberdeen、Scotland、英国、AB25 2ZN
- Aberdeen Royal Infirmary
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Wales
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Cardiff、Wales、英国、CF14 2TL
- Velindre Cancer Center at Velindre Hospital
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-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed primary epidermoid anal cancer
- Squamous cell
- Basaloid
- Cloacogenic
- No adenocarcinoma, malignant melanoma, mucoepidermoid carcinoma, lymphoma, or microinvasive anal intraepithelial neoplasia (without evidence of invasive disease) in the anal canal or margin
- No metastatic disease
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic:
- Liver function tests no greater than 2 times normal
Renal:
- Glomerular filtration rate at least 50 mL/min
Cardiovascular:
- No cardiovascular disease
- No uncontrolled angina pectoris
- No heart failure
- No clinically significant cardiac arrhythmias
Other:
- HIV negative
- No other significant concurrent illness
- Not predominately bed-bound or frail
- No severe sepsis
- No other prior or concurrent cancer or illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to pelvis
Surgery:
- Not specified
Other:
- No prior therapy for anal cancer
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 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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无复发生存
|
Complete response rate at 6 months
|
Acute toxicity as measured up to 4 weeks after chemoradiation
|
次要结果测量
结果测量 |
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Colostomy rate
|
In field recurrence rate as measured by confirmed disease within radiation therapy field
|
Cause-specific and overall survival
|
合作者和调查者
调查人员
- 学习椅:Roger D. James, MD、Maidstone Hospital
研究记录日期
研究主要日期
学习开始
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 (估计)
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
- CDR0000068911
- NCRI-ACT-II
- EU-20056
- UKCCCR-ACT-II
- ISRCTN26715889
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