A Prospective Randomized Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation
概览
- 阶段
- 不适用
- 干预措施
- Radiation Therapy to partial breast
- 疾病 / 适应症
- Breast Cancer
- 发起方
- Weill Medical College of Cornell University
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
The Investigators are investigating the potential role of MRI-guided Radiation Therapy for patients receiving breast radiotherapy in the prone position with a MRI-Linac radiotherapy system, the Precision Prone Irradiation (PPI) technique.
Hypothesis: The investigators would like to hypothesize that breast radiation therapy using MRI-guided system including the MRI-Linac (Arm 2) is comparable to the current standard of treatment using conventional CT-based system (Arm 1), in terms of local control of the disease at 2 year time point.
详细描述
Breast conserving surgery and adjuvant whole breast radiotherapy is a standard treatment option for most patients with early-stage invasive breast cancer. Recent technological advances in radiotherapy have enabled shorter treatment courses, smaller radiation fields, prone positioning, and fewer side effects associated with breast cancer treatment. To further improve target accuracy in breast radiation delivery, an emerging radiotherapy technology takes advantage of on-table MRI imaging and daily adaptive planning during the radiation delivery process. The objectives of the study are to compare side effects in patients treated under either of these treatment settings and to compare recurrence (if the cancer comes back) rates at a 2-year time point. Patients will have annual follow ups up to 10 years and recurrence rates will be measured at 5-year and at 10-year time points.
研究者
入排标准
入选标准
- •Patients ≥ 50 yrs with histologically confirmed unilateral DCIS or Stage I invasive breast cancer; received breast conserving surgery (pN0 or pNx) with tumor pathology ≤ 2 cm and excision margin ≥ 1 mm
- •Inclusion Criteria:
- •Women status post segmental mastectomy
- •If unilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
- •If bilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
- •Clinically N0 or pN0 or sentinel node negative
- •Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).
排除标准
- •Previous radiation therapy to the ipsilateral breast.
- •\> 90 days from last surgery, unless s/p adjuvant chemotherapy
- •\> 60 days from last chemotherapy
- •Patients unable to tolerate MRI or are otherwise unsuitable for MRI-based RT treatment
- •Metastatic disease
研究组 & 干预措施
ARM 1 - CT-based breast radiation treatment
Patients randomized to ARM 1 will receive 3000 cGy in 5 fractions partial breast radiotherapy with CT-based breast radiation treatment.
干预措施: Radiation Therapy to partial breast
ARM 2 - MRI-based breast radiation treatment
Patients randomized to ARM 2 will receive 3000 cGy in 5 fractions partial breast radiotherapy with MRI-based breast radiation treatment.
干预措施: Radiation Therapy to partial breast
结局指标
主要结局
Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)
时间窗: 24months
次要结局
- Comparing number of participants with local recurrence between patients treated on Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)(120 months)
- Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)(24 months)
- Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)(60 months)
- Comparing clinical and planning target volumes (CTV and PTV volumes) for CT-based planning vs. MRI-based planning(60 months)
- Comparing patient reported cosmetic outcomes between patients treated on Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)(60 months)
- Comparing the number of treatment related acute skin toxicities observed in patients who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)(24 months)
- Comparing the number of treatment related acute skin toxicities observed in patients who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)(6 months)
- Comparing the number of treatment related acute skin toxicities observed in patients who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)(12 months)
- Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)(6 months)
- Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)(12 months)