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临床试验/NCT00470236
NCT00470236Unknown不适用

A Randomised Phase III Study of Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast

Trans Tasman Radiation Oncology Group158 个研究点 分布在 3 个国家目标入组 1,608 人开始时间: 2007年6月1日最近更新:
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适应症

试验速览

阶段
不适用
发起方
入组人数
1,608
试验地点
158
主要终点
Time to local recurrence, measured from the date of randomization to the date of first evidence of local recurrence.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Hypotheses:

  1. The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast).
  2. The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm.
  3. A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization.

Overall Objectives:

  1. To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy.
  2. To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.

详细描述

Specific objectives:

  1. To evaluate time to local recurrence in women with DCIS treated with breast conserving surgery followed by:
  • whole breast RT alone versus whole breast RT plus tumour bed boost;
  • RT using the standard fractionation schedule versus the shorter schedule.
  1. To evaluate time to disease recurrence and overall survival in women with DCIS treated with breast conserving surgery followed by:
  • whole breast RT alone versus whole breast RT plus tumour bed boost;
  • RT using the standard fractionation schedule versus the shorter schedule.
  1. To compare the toxicity of:
  • whole breast RT alone versus whole breast RT plus tumour bed boost;
  • RT using the standard fractionation schedule versus the shorter schedule.
  1. To compare the cosmetic outcome of:

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
18 Years 至 —（Adult, Older Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •Patients must fulfill all of the following criteria for admission to study:
  • •Women ≥ 18 years.
  • •Histologically proven DCIS of the breast without an invasive component.
  • •Bilateral mammograms performed within 6 months prior to randomization.
  • •Clinically node-negative.
  • •Treated by breast conserving surgery (primary excision or re-excision) with complete microscopic excision and clear radial margins of ≥1 mm* (*Patients with superficial or deep resection margin of <1 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia).
  • •Women who are at high risk of local recurrence due to:
  • •Age < 50 years; OR
  • •Age ≥ 50 years plus at least one of the following:
  • •Symptomatic presentation
  • •Palpable tumour
  • •Multifocal disease
  • •Microscopic tumour size ≥ 1.5 cm in maximum dimension
  • •Intermediate or high nuclear grade
  • •Central necrosis
  • •Comedo histology
  • •Radial* surgical resection margin < 10 mm. (*Patients with superficial or deep resection margin of < 10 mm are eligible if surgery has not removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.)
  • •Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy including whole breast RT.
  • •Ability to tolerate protocol treatment.
  • •Protocol RT should preferably commence within 8 weeks but must commence no later than 12 weeks from the last surgical procedure.
  • •ECOG performance status 0, 1 or
  • •Patient's life expectancy > 5 years.
  • •Availability for long-term follow-up.
  • •Written informed consent.

排除标准

  • •Patients who fulfill any of the following criteria are not eligible for admission to study:
  • •Multicentric disease or extensive microcalcifications that could not be completely excised by breast conserving surgery with radial margins of ≥1 mm*.
  • •*Patients with superficial and/or deep margin of <1 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.
  • •Presence of tumour cells in lymph nodes detected using H&E or immunohistochemical examination (if lymph node biopsy or dissection has been performed).
  • •Locally recurrent breast cancer.
  • •Previous DCIS or invasive cancer of the contralateral breast.
  • •Bilateral DCIS of the breasts
  • •Synchronous invasive carcinoma of the contralateral breast
  • •Other concurrent or previous malignancies except:
  • •Non-melanomatous skin cancer;
  • •Carcinoma in situ of the cervix or endometrium; and
  • •Invasive carcinoma of the cervix, endometrium, colon, thyroid and melanoma treated at least five years prior to study admission without disease recurrence.
  • •Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g., scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).
  • •ECOG performance status ≥
  • •Women who are pregnant or lactating.

结局指标

主要结局

Time to local recurrence, measured from the date of randomization to the date of first evidence of local recurrence.

时间窗: Main analysis after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up.

次要结局

  • Quality of Life change(Assessed at baseline, last week of RT, 6, 12, 24, 60 & 120 months post RT.)
  • Time to disease recurrence(Measured from the date of randomization to the date of first evidence of recurrent disease. Main analysis of secondary outcomes after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up.)
  • Cosmetic Outcome(Cosmetic assessment will take place at baseline, 12, 36 and 60 months post RT.)
  • Radiation toxicity(Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10.)
  • Overall survival(Measured from the date of randomization to the date of death from any cause. Main analysis of secondary outcomes after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up.)

研究者

发起方
Trans Tasman Radiation Oncology Group
申办方类型
Other
责任方
Sponsor

研究点 (158)

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