ACTRN12607000238471已完成不适用
Trans Tasman Radiation Oncology Group (TROG) 06.02 - A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation (APBI) Using Three-Dimensional Conformal Radiation Therapy for Early Breast Cancer to test the feasibility of APBI.
Trans Tasman Radiation Oncology Group (TROG)0 个研究点目标入组 48 人开始时间: 2007年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Patients must fulfil all of the following criteria for admission to study:- Women aged >= 50 years.- Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.- Bilateral mammograms performed within 6 months prior to registration.- Treated with breast conserving surgery (primary excision or re-excision) with negative radial resection margins of >= 2 mm* for both the invasive and if present, associated intraductal tumour.*Patients with superficial or deep resection margin of < 2 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.- Unifocal tumour measuring <= 20 mm in maximum microscopic dimension.- Negative nodal status determined by sentinel node biopsy, axillary dissection, or for women >70 years of age, clinical examination.- No evidence of distant metastasis.- Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy.- Ability to tolerate protocol therapy.- Protocol therapy must commence no later than 12 weeks from the last surgical procedure or 8 weeks from the last dose of chemotherapy.- Availability for long-term follow-up.- Women of child-bearing potential must use adequate contraception during RT.- Written informed consent.
排除标准
- •Patients who fulfil any of the following criteria are not eligible for admission to study:- Multifocal or multicentric tumours.- Clinical or pathologic evidence of any of the following tumour features: extension to chest wall (excluding pectoralis muscle); oedema (including peau d’orange) or ulceration of skin; satellite skin nodules confined to the same breast; and inflammatory carcinoma.- Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25% of the primary invasive tumour and present adjacent to the primary tumour).- Node-positive breast cancer determined by sentinel node biopsy, axillary dissection, or in women > 70 years of age, clinical examination.- Inability to localise surgical cavity on CT scans with no evidence of a surgical cavity, seroma or surgical clips delineating the tumour bed.- Treatment target volume estimated to occupy > 25% of the ipsilateral whole breast volume - Synchronous or metachronous bilateral invasive or intraductal breast cancer.- Locally recurrent breast cancer.- Ipsilateral breast implant.- Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).- Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix or endometrium treated five years prior to study entry.- Women who are pregnant or lactating.- Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
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