Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 7
- 主要终点
- Response rate
研究概览
简要总结
This clinical trial tests how well ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) works in treating patients with stage I-III breast cancer. Breast conservation therapy (BCT) is the recommended treatment for patients with early stage breast cancer. BCT involves a lumpectomy followed by breast radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Traditionally, WBI has been given once daily over 5-6 weeks and then those at high-risk for recurrence receive additional radiation (boost) to the lumpectomy cavity daily over 4-8 days. This has now been replaced by moderate hypofractionated radiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Although moderate hypofractionated radiation therapy reduces the length of treatment from 6-7 weeks to 3-4 weeks, the length of treatment still remains a barrier for many patients. UF-WBI with CB delivers radiation to the whole breast and the surgical cavity at the same time over 5 daily treatments. Giving UF-WBI with CB may prevent recurrence and prolong survival as well as improve the quality of life in patients with stage I-III breast cancer.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the impact of UF-WBI + CB as assessed by patient-reported Global Cosmesis Score (GCS) at 1 year.
SECONDARY OBJECTIVES:
I. To characterize the patient-reported cosmetic appearance of the breast over time, as assessed by GCS.
II. To determine short- and long-term physician-reported cosmetic appearance of the breast, as assessed by GCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Documented informed consent of the participant and/or legally authorized representative
- •Age: ≥ 40 years
- •Ability to read and understand English for questionnaires
- •Histologically confirmed breast cancer
- •Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed
- •Patients must have undergone breast conserving surgery. Re-excision for negative margins is allowed
- •Patients must have undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection)
- •Must have at least one-high risk feature that would necessitate a lumpectomy cavity boost by the treating radiation oncologist
- •Patient must have physician-reported "Excellent" or "Good" cosmesis post-lumpectomy and prior to radiation therapy based on the 4-point Global Cosmetic Score
- •Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
- •If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
排除标准
- •Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude breast irradiation
- •Pathologically or clinically involved regional lymph nodes necessitating comprehensive regional nodal irradiation that includes the supraclavicular fossa
- •Clinically significant uncontrolled illness
- •Stage IV breast cancer
- •Diagnosis of Paget's disease of the nipple
- •Other prior or active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- •Pregnant or breastfeeding
- •Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
研究组 & 干预措施
Treatment (UF-WBI with CB)
Patients undergo UF-WBI with CB QD on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CBCT prior to each radiation treatment.
干预措施: Radiation Boost (Radiation)
Treatment (UF-WBI with CB)
Patients undergo UF-WBI with CB QD on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CBCT prior to each radiation treatment.
干预措施: Cone-Beam Computed Tomography (Procedure)
Treatment (UF-WBI with CB)
Patients undergo UF-WBI with CB QD on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CBCT prior to each radiation treatment.
干预措施: Hypofractionated External Beam Radiation Therapy (Radiation)
Treatment (UF-WBI with CB)
Patients undergo UF-WBI with CB QD on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CBCT prior to each radiation treatment.
干预措施: Questionnaire Administration (Other)
Treatment (UF-WBI with CB)
Patients undergo UF-WBI with CB QD on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CBCT prior to each radiation treatment.
干预措施: Whole Breast Irradiation (Radiation)
结局指标
主要结局
Response rate
时间窗: At 1 year
Responding patients are defined as patients with a rating of either "excellent" or "good" on the 4-point Global Cosmesis Score (GCS). Will be estimated along with the 95% exact binomial confidence interval.
次要结局
- Patient-reported cosmetic outcome using GCS - 3 years(At 3 years)
- Patient-reported cosmetic outcome using GCS - Baseline(At baseline)
- Patient-reported cosmetic outcome using GCS - 6 months(At 6 months)
- Patient-reported cosmetic outcome using GCS - 1 year(At 1 year)
- Patient-reported cosmetic outcome using GCS - 2 years(At 2 years)
- Physician-reported cosmetic outcome using GCS(At baseline, at 6 months and at years 1, 2, and 3)
- Patient-reported radiation-associated toxicities(At 1 month, 6 months, and 1 year)
- Physician-reported radiation-associated toxicities(At 1 month, 6 months, and years 1, 2, and 3)
- Incidence of in-breast disease recurrence(Up to 5 years)
- Incidence of metastatic disease(Up to 5 years)
- Disease free survival(From start of treatment to in-breast recurrence, metastatic disease, or death from any cause, whichever occurs first, assessed up to 5 years)
- Overall survival(From start of treatment to death from any cause, assessed up to 5 years)