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临床试验/NCT03710018
NCT03710018Unknown不适用

Localisation of Tumor Bed and Its Impact on Dosimetry for Tumor Bed Boost Irradiation in Patients Treated With Breast Conserving Surgery Using Different Techniques

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
21
试验地点
1
主要终点
Volume of PTV

研究概览

简要总结

PRIMARY STUDY OBJECTIVES:

To evaluate dosimetric outcomes in tumor bed boost irradiation in patients undergoing breast conservative surgery using three different surgical techniques SECONDARY OBJECTIVES- Evaluation of cosmesis in patients prior to radiotherapy, at the time of completion of radiotherapy and 6 months post completion of radiotherapy STUDY DESIGN: Three arm, Prospective Observational Trial

TREATMENT REGIMEN:

Group A- Patients who underwent open cavity Breast Conservative surgery(BCS) Group B- Patients who underwent closed cavity BCS Group C- Patients who underwent oncoplasty All patients will first receive external beam Radiotherapy to the whole breast to a dose of 40 Grays /15#/3 weeks. The patients will then be planned for boost radiation to the tumor bed to a dose of 12.5 Grays/5#.

RECRUITMENT TARGET: 20 Patients The sample size has not been calculated as this is a pilot study. Twenty patients will be accrued for the purpose of this study

PRIMARY ENDPOINT

  1. Dosimetric Measurement
  • Seroma cavity volume (ccs).
  • PTV volume (ccs).
  • Ratio between the PTV volumes to the whole breast volume
  • Radiation Conformity Index (RCI)
  • Dose Homogeneity Index (DHI)
  • Ratio of dose received by 95% of PTV volume to the dose received by 5% of PTV volume
  • Dose received by several normal structures; normal ipsilateral breast tissue, contralateral breast, ipsilateral lung, contralateral lung, and heart
  1. Cosmesis Measurement
  • prior to starting radiotherapy,
  • at the time of conclusion of radiotherapy
  • 6 months post completion of radiotherapy

详细描述

Introduction:

For patients with early stage invasive disease, surgery can either be a breast conserving resection of the primary tumor or a mastectomy. Several randomized prospective clinical trials have indicated that breast conserving surgery with whole breast radiation provides long term outcomes equivalent to those of mastectomy. The goal of breast conserving surgery is to remove the primary tumor with surgical margins that are free from invasive or in-situ disease. A secondary goal is to provide the best possible cosmetic outcome without retraction, nipple displacement, or excess volume loss from the procedure. For some women with larger breasts, oncoplastic surgery can be used in which local tissue rearrangements are performed at the time of surgical resection to maintain optimal breast aesthetics

Radiation is essential component of breast conserving therapy. The use of RT improved recurrence free, breast cancer specific survival and overall survival in both patients with negative and positive axillary lymph nodes in the most recent meta-analysis of Early Breast Cancer Trialists Collaborative Group(EBCTCG)5 which included trials begun before 2000.It included data from 42080 patients with breast cancer treated in 78 clinical trials that investigated loco regional treatments between 1952 and 1995.Among those patients were 7311 patients treated in 10 trials comparing radiation vs no radiation after breast conserving surgery and 9933 patients treated in 25 trials comparing radiation vs no radiation after modified radical mastectomy. In the trials that investigated radiation as a component of breast conserving therapy, radiation was shown to reduce the risk of local recurrence by two thirds and to improve the absolute 15 year overall survival rate by 6% (41% versus 35%).Similarly for patients with positive lymph nodes treated with modified radical mastectomy, radiation reduced the risk of loco-regional recurrence rate by 21% at 15 years(29% versus 8%), which was associated with a 5% decrease in the 15 year breast cancer mortality rate (60% versus 55%).A more recent update of the analyses continues to demonstrate loco-regional and survival advantages for radiation therapy

Even if surgical margins are negative after BCS, 30-40% risk of microscopic tumor cells in tumor bed. Most recurrences (65-80%) are located in vicinity of tumor bed as shown in EORTC6 trial and NSABP-06 trial. It is therefore important to ensure the tumor bed lies well inside the treatment volume encompassed by tangential fields to whole breast and subsequent tumor bed boost. There is also a pathological basis for giving boost to tumor bed-residual tumor foci have been reported in 1-2 cm in around 20-25% patients/ histopathological specimens.

The EORTC 22881-108827 trial studied the effect of addition of a boost dose on the primary tumor bed after lumpectomy in breast conserving treatment for breast cancer.It was found that 47% of local recurrences were in primary tumor bed, at 10 years, the cumulative incidence of local recurrence was 10.2% versus 6.2% for the 0 Grays and the 16 Grays boost groups (p< 0.0001).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.All patients undergoing Breast Conservative Surgery (Open Cavity/Closed Cavity) or Oncoplasty will be eligible for this study.

排除标准

  • Patients undergoing Neoadjuvant chemotherapy will not be eligible for the purpose of this study.
  • All patients undergoing Modified Radical Mastectomy will not be eligible for the purpose of this study

结局指标

主要结局

Volume of PTV

时间窗: at the time of radiation planning

measured in cubic centimeter

PTV coverage by 95% isodose line

时间窗: at the time of radiation planning

measured in percent

次要结局

  • Cosmesis(on day of radiotherapy simulation, at 4 weeks post radiotherapy simulation and at 6 month post radiotherapy simulation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ashwini Budrukkar

Associate Professor, Radiation Oncology

Tata Memorial Centre

研究点 (1)

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