Phase III Randomized Study of Adjuvant Whole Breast Versus Partial Breast Irradiation Using Once Daily or Twice Daily Fractionation Scheme in Women With Stage I or II Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change in the Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System
研究概览
简要总结
This is a randomized phase III trial in women with invasive carcinoma of the breast with negative axillary nodes treated by Breast Conserving Surgery (BCS). Eligible, patients will be randomly allocated to receive radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Whole Breast Irradiation (WBI) 50 Gray (Gy) in 25 daily fractions over 5 weeks or Accelerated Partial Breast Irradiation (APBI) 38.5 Gy in 10 daily fractions of 3.85Gy over two weeks or 38.5 Gy in 10 twice daily fractions of 3.85Gy over one week. Patients will be followed at 6, 12, 18 and 24 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 less than 3 cm with negative axillary nodes , following BCS, who meet the inclusion criteria will be approached for potential study enrollment.
Eligible, consenting patients will be randomly allocated to receive radiotherapy of 3DCRT WBI 50 Gy in 25 fractions over 5 weeks or APBI 38.5 Gy in 10 once daily fractions of 3.85Gy over two weeks or 38.5 Gy in 10 twice daily fractions of 3.85 Gy over one week. Patients will be followed at 6, 12, 18 and 24 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 4.0. The primary outcome is to compare the acute, late toxicities and adverse cosmetic outcomes at 6, 12 and 18 months among the three groups.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Tumor characteristics
- •Histologically confirmed invasive adenocarcinoma of the breast
- •Tumors must be ≤ 3 cm. Gross disease must be unifocal. Negative lymph nodes
- •Hormone receptor status:
- •Estrogen receptor (ER) status known Progesterone status known if ER analysis is negative Marginal or borderline results are considered positive Surgery
- •Tumor removed with conservative breast surgery with adequate margin
- •Re-excision of surgical margins allowed
- •No prior breast implants
- •Prior axillary staging required for patients including 1 of the following:
- •Sentinel node biopsy alone (if sentinel node is negative)
- •Sentinel node biopsy followed by axillary dissection if sentinel node is positive)
- •Axillary dissection alone with ≥ 6 axillary nodes
- •Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume ≤ 30% based on postoperative pre-randomization CT scan
- •Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days
- •No prior biologic therapy for this malignancy Chemotherapy
- •No prior chemotherapy for this malignancy
- •No concurrent chemotherapy during study radiotherapy Endocrine therapy
- •No prior hormonal therapy for this malignancy
- •Concurrent hormonal therapy allowed provided it is not administered during chemotherapy
- •No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulating drugs
- •No concurrent hormone replacement therapy Radiotherapy
- •No prior radiotherapy for this malignancy
- •No prior breast or thoracic radiotherapy
- •No concurrent regional nodal irradiation Other
- •No other concurrent anticancer therapy Menopausal status
- •Premenopausal or postmenopausal Performance status
- •WHO 0-1 Other
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective non-hormonal contraception
排除标准
- •Multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm.
- •Non-epithelial breast malignancies (e.g., sarcoma or lymphoma).
- •Positive axillary nodes.
- •Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor.
- •Suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign
- •Paget's disease of the nipple
- •Previous history of invasive breast cancer or DCIS.
- •Synchronous bilateral invasive or non-invasive breast cancer
- •Collagen vascular disease (e.g., systemic lupus erythematosus or scleroderma), specifically dermatomyositis with a CPK level above normal, or active skin rash
- •Psychiatric or addictive disorder that would preclude study therapy
结局指标
主要结局
Change in the Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System
时间窗: prior to radiation, 6,12 and 18 months after radiation
The primary outcome is the change in the adverse cosmesis assessed prior to radiation, 6, 12 and 18 months after end of radiation. The cosmetic outcome will be assessed by a radiation oncologist who is unaware of treatment allocation, using the EORTC Breast Cosmetic Rating System.
次要结局
- Disease Free Survival(throughout the study up to 5 years)
- Overall Survival(From date of randomization until the date of death up to 5 years)
- Ipsilateral Breast Tumor Recurrence (IBTR)(throughout the study up to 5 years)
- Radiation Induced Early and late toxicities(during radiation and at 6, 12 and 18 months after radiation)
研究者
Rimoun Ramsis Anis Boutrus
Lecturer of Radiation Oncology
National Cancer Institute, Egypt