Radiation Therapy in Women With Low Risk Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery (IMPORT)
Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy is more effective than standard radiation therapy in treating patients with early-stage breast cancer.
PURPOSE: This randomized phase III trial is comparing radiation therapy regimens in treating women with early-stage breast cancer who have undergone breast-conservation surgery.
研究概览
详细说明
OBJECTIVES:
- To test partial breast radiotherapy using intensity-modulated techniques following complete local tumor excision in women with low-risk, early stage breast cancer.
OUTLINE: This is a multicenter study.
Patients are stratified according to center (not participating in sub-studies vs participating in sub-studies). Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo standard whole breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.
- Arm II: Patients undergo reduced whole breast radiotherapy (15 fractions) and standard partial breast radiotherapy (15 fractions) once daily on days 1-5 for 3 weeks.
- Arm III: Patients undergo standard partial breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.
All patients complete a family history questionnaire at baseline. Patients also undergo blood sample collection at baseline and paraffin-embedded tissue collection at follow-up for molecular studies analyzing inter-patient variation by microarrays.
Patients in centers participating in sub-studies undergo quality of life and health economic assessment at baseline, 6 months, and 1, 2, and 5 years. These patients also undergo photographic assessment at baseline, 2 years, and 5 years.
After completion of study treatment, patients are followed for 10 years.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
England
-
Sutton、England、英国、SM2 5PT
- Royal Marsden - Surrey
-
-
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:
Diagnosis of low-risk early stage breast cancer, meeting the following criteria:
Invasive adenocarcinoma
- No invasive carcinoma of classical lobular type
- lympho-vascular invasion present or absent
- Tumor size pathologically determined to be ≤ 3.0 cm in diameter (pT1-2) (< 3.1 cm maximum microscopic diameter of invasive component)
- Unifocal disease
- Grade I, II, or III disease
- Axillary lymph nodes negative or 1-3 nodes positive (pN0 or pN+(1-3))
Must have undergone breast conservation surgery with or without adjuvant systemic therapy
- Minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia)
- At low risk of local recurrence after radiotherapy (< 1% annual risk local recurrence)
- No prior mastectomy
- No blood-borne metastases
PATIENT CHARACTERISTICS:
- No prior malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
No prior endocrine therapy or chemotherapy
- Neoadjuvant endocrine therapy allowed provided the tumour is < 3.0 cm and all other inclusion criteria are met
- No primary endocrine therapy as a replacement for surgery
- No concurrent chemoradiotherapy
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
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Arm I (control)
Patients undergo standard whole breast radiotherapy once daily on days 1-5 for 3 weeks.
|
Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
|
|
实验性的：Arm II
Patients undergo reduced whole breast radiotherapy and standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
|
Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
|
|
实验性的：Arm III
Patients undergo standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
|
Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment
大体时间：5 years
|
5 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Location of tumor relapse
大体时间：5 years
|
5 years
|
|
Contralateral primary breast cancer or other primary tumors as confirmed by cytological or histological assessment
大体时间：5 years
|
5 years
|
|
Regional and distant metastases
大体时间：5 years
|
5 years
|
|
Late adverse effects in normal tissue normal tissues as determined periodically by photographic assessments (in a subset of patients), physician assessments, and patient self-assessments
大体时间：5 years
|
5 years
|
|
Quality of life as assessed by EORTC QLQ C-30, EORTC QLQ-BR23, BIS, and HADS questionnaires in a subset of patients at baseline, 6 months, and 1, 2, and 5 years
大体时间：5 years
|
5 years
|
|
Cost-effectiveness as assessed by EQ-5D questionnaire at baseline, 6 months, and 1, 2, and 5 years
大体时间：10 years
|
10 years
|
合作者和调查者
调查人员
- 首席研究员：Charlotte E Coles, PhD、University of Cambrige, England
出版物和有用的链接
一般刊物
- Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2.
- Bhattacharya IS, Haviland JS, Kirby AM, Kirwan CC, Hopwood P, Yarnold JR, Bliss JM, Coles CE; IMPORT Trialists. Patient-Reported Outcomes Over 5 Years After Whole- or Partial-Breast Radiotherapy: Longitudinal Analysis of the IMPORT LOW (CRUK/06/003) Phase III Randomized Controlled Trial. J Clin Oncol. 2019 Feb 1;37(4):305-317. doi: 10.1200/JCO.18.00982. Epub 2018 Dec 11.
- Kirby AM, Bhattacharya IS, Wilcox M, Haviland JS. The IMPORT LOW Trial: Collaborative Research Accelerates Practice Change in Breast Radiotherapy. Clin Oncol (R Coll Radiol). 2019 Jan;31(1):5-8. doi: 10.1016/j.clon.2018.08.007. Epub 2018 Sep 17. No abstract available.
- Coles C, Yarnold J; IMPORT Trials Management Group. The IMPORT trials are launched (September 2006). Clin Oncol (R Coll Radiol). 2006 Oct;18(8):587-90. doi: 10.1016/j.clon.2006.07.010. No abstract available.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
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
其他研究编号
- CDR0000629768
- NIHR 2253 (其他标识符：NIHR)
- ICR-CTSU/2006/10001 (其他标识符：ICR-CTSU)
- ISRCTN12852634 (注册表标识符：ISRCTN)
- CRUK/06/003 (其他赠款/资助编号：Cancer Research UK)
- 06/Q1605/128 (其他标识符：Main Research Ethics Committee)
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
radiation therapy的临床试验
-
University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的
-
Abbott Medical Devices完全的
-
University of Southern CaliforniaNational Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute of Child... 和其他合作者完全的