A Phase II Randomized Trial of Radiation Fractionation Schedules for Once-a-Day Accelerated Partial Breast Irradiation (OPAR)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 20
- 主要终点
- Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System
研究概览
简要总结
This is a multi-centre randomized phase II trial in women with invasive carcinoma of the breast with negative axillary nodes or Ductal Carcinoma In-situ (DCIS) treated by Breast Conserving Surgery (BCS). Eligible, consenting patients will be randomly allocated to receive radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Accelerated Partial Breast Irradiation (APBI) 30 Gray (Gy) in 5 daily fractions of 6Gy or 27.5Gy in 5 daily fractions of 5.5Gy over one week. Patients will be followed at 12, 24, 36 and 60 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists. Radiation toxicity will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
详细描述
Women with invasive carcinoma of the breast with negative axillary nodes or DCIS, following BCS and/or chemotherapy, who meet the inclusion criteria will be screened and approached for eligibility assessment and potential study enrollment. All potentially eligible and consenting patients who do not meet the exclusion criteria will have a Computed Tomography (CT) simulation of the ipsilateral breast prior to randomization. All cases will be required to be planned prior to the randomization to ensure that dosimetric coverage and normal tissue restrictions can be met. If the seroma is not clearly visible or if the surgical clips do not adequately identify a previous surgical cavity, the patient will not be eligible for randomization.
Eligible, consenting patients will be randomly allocated to receive radiotherapy of 3DCRT APBI 30Gy in 5 daily fractions of 6Gy or 27.5Gy in 5 daily fractions of 5.5Gy over one week. Patients will be followed at 12, 24, 36 and 60 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists using the EORTC Breast Cosmetic Rating System. Radiation toxicity will be assessed using the NCI CTCAE version 4.02. The primary outcome is adverse cosmetic outcome at 2 years. The trial will be conducted in clinical centres within Canada.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with a new histological diagnosis of DCIS or invasive carcinoma of the breast with no evidence of metastatic disease.
- •Treated by BCS with microscopically clear resection margins for invasive and non-invasive disease (or no residual disease on re-excision).
- •Negative axillary node involvement, including positive cells only identified by Immunohistochemistry (IHC) as determined either by sentinel node biopsy or axillary node dissection, or a clinical exam for patients with DCIS only.
排除标准
- •Age less than 50 years
- •Known to be Breast Cancer Type 1 Susceptibility Protein (BRCA 1) and/or Breast Cancer Type 2 Susceptibility Protein (BRCA 2) positive
- •Tumour size >3 cm in greatest diameter on pathological examination (including the invasive and non-invasive components)
- •Tumour invades the skin (i.e. T4 disease)
- •Tumour histology limited to lobular carcinoma only
- •Grade III invasive breast carcinoma or nuclear grade III for patients with DCIS alone
- •Triple negative invasive breast cancer
- •Her2+ve invasive breast cancer that will not receive Herceptin
- •Bilateral invasive malignancy of the breast (synchronous or metachronous)
- •More than one primary tumor in different quadrants of the same breast
- •Presence of an ipsilateral breast implant or pacemaker
- •Status for adjuvant systemic therapy not determined
- •Unable to commence radiation therapy:
- •within 12 weeks of the last surgical procedure on the breast, or
- •within 8 weeks of the last dose of chemotherapy
- •Previous or concurrent malignancies except:
- •Non-melanoma skin cancer
- •Carcinoma in-situ of the cervix
- •Invasive carcinoma of the cervix, endometrium, colon and thyroid, treated 5 years prior to study entry with no evidence of disease
- •Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
- •Current pregnancy or lactating.
- •Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to the protocol.
- •Geographic inaccessibility for follow-up.
- •Inability to localize surgical cavity on CT (i.e. no evidence of surgical clips or seroma)
- •Inability to adequately plan the patient for the experimental technique.
结局指标
主要结局
Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System
时间窗: 2 years post randomization
The primary outcome is adverse cosmesis assessed at 2 years post randomization as determined by photographic assessment. The cosmetic outcome will be assessed by a panel of 3 trained radiation oncologists who are unaware of treatment allocation, using the EORTC Breast Cosmetic Rating System for cosmetic results for breast conserving treatment. The treated breast is compared with the untreated breast for size, shape, location of the areola/nipple, appearance of the surgical scar, presence of telangiectasia, and a global cosmetic score based on these factors. Characteristics are graded on a 4-point scale: 0 = excellent; 1 = good; 2 = fair; 3 = poor. A global cosmetic score of fair or poor will be used as the primary outcome of adverse cosmesis.
次要结局
- Disease free survival (DFS)(Ongoing throughout study up to 5 years)
- Radiation toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.02(12, 24, 36 and 60 months)
- Cosmetic deterioration (defined as any adverse change in the global cosmetic score)(Baseline to two years)
- Ipsilateral breast tumour recurrence (IBTR)(Ongoing throughout study up to 5 years)
- Overall survival (OS)(From date of randomization until the date of death up to 5 years)