ACTRN12607000246482进行中（未招募）3 期
Trans Tasman Radiation Oncology Group (TROG) 07.01 - A randomised phase III study of radiation doses and fractionation schedules in non-low risk Ductal Carcinoma In Situ (DCIS) of the breast to improve time to recurrence
Trans Tasman Radiation Oncology Group Ltd0 个研究点目标入组 1,608 人开始时间: 2007年5月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,608
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1. Women aged >18years.
- •2. Histologically proven DCIS of the breast without an invasive component.
- •3. Bilateral mammograms performed within 6 months prior to randomisation.
- •3. Clinically node-negative.
- •4. Treated by breast conserving surgery (primary excision or re-excision) with complete microscopic excision and clear radial margins of greater than or equal to 1mm (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)
- •5. 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: a) Symptomatic presentation
- •b) Palpable tumour c) Multifocal disease
- •d) Microscopic tumour size = 1.5 cm in maximum dimension e) Intermediate or high nuclear grade f) Central necrosis
- •g) Comedo histology h) 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.
- •6. Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy including whole breast RT.
- •7. Ability to tolerate protocol treatment.
- •8. Protocol RT should preferably commence within 8 weeks but must commence no later than 12 weeks from the last surgical procedure
- •9. ECOG performance status 0, 1 or 2.
- •10. Patient’s life expectancy > 5 years
- •11. Availability for long-term follow-up.
- •12. Written informed consent.
排除标准
- •Patients who fulfil any of the following criteria are not eligible for admission to study:-
- •1. Multicentric disease or extensive microcalcifications that could not be completely excised by breast conserving surgery with radial margins of greater than or equal to 1mm (Patients with superficial and/or deep margin of < 1mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia)
- •2. Presence of tumour cells in lymph nodes detected using H&E or immunohistochemical examination (if lymph node biopsy or dissection has been performed).
- •3. Locally recurrent breast cancer.
- •4. Previous DCIS or invasive cancer of the contralateral breast.
- •5. Other concurrent or previous malignancies except: a) Non-melanomatous skin cancer; b) Carcinoma in situ of the cervix or endometrium; and
- •c) Invasive carcinoma of the cervix, endometrium, colon, thyroid and melanoma treated at least five years prior to study admission without disease recurrence.
- •6. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).- 7. ECOG performance status = 3.
- •8. Women who are pregnant or lactating.
研究者
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