Comparative Study Between Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of Acute grade 2 or higher toxicity (NCI-CTCAE)
研究概览
简要总结
Prospective randomized study comparing 5 fractions in alternative days to standard 15 fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner patients aged above 50 years
详细描述
In Alexandria, the number of working linear machines are limited with overcrowded waiting list which lead to prolongation of overall treatment time and delay in starting radiotherapy. Providing the available data, Principle investigator is conducting this study in parallel with fast forward protocol to provide an alternative cost effective approach to patients.
The rationale behind hypofractionation depends mainly on the alpha beta ratio (α/β) and the overall treatment time. In Breast cancer the ratio is around 4 which is slightly lower than other tumors such as head and neck. The lower the ratio the higher the dose per fraction is needed to compensate slower proliferating tumors. Also, the overall treatment time could affect the local recurrence of breast cancer which is increased with long duration of treatment.
This study will include at least 100 patients with non metastatic histologically proved breast cancer who are indicated for adjuvant radiotherapy.
The patients will be randomized into two arms:
- Control arm: will include 50 patients who will receive standard 40.05 Gray (2.67 Gy/fx) over 15 fractions with or without boost over 3 weeks biologically effective dose (BED) for early and late effect equal 50.74.Gy10 and 75.69 Gy3 respectively.
- Experimental arm: will include 50 patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks with BED for early and late effect equal 39.52 Gy10 and 71.07 Gy3 respectively
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
- None
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
- •Age ≥50 years old.
- •Informed consent.
- •Either breast conservative surgery or mastectomy.
- •Invasive breast cancer with p T1-3, p N0-
- •Non metastatic breast cancer proven by clinical examinations and imaging (X-ray chest and ultrasound or CT scan chest and abdomen).
排除标准
- •Evidence of distant metastases.
- •Prior irradiation.
- •Inflammatory breast cancer.
- •Tumor with T4 (skin nodules or fixed to chest wall or ulceration).
- •Tumor with positive margins.
研究组 & 干预措施
Hypofractionation
Control arm:patients who will receive standard 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
干预措施: Hypofractionation (Radiation)
Ultrahypofractionation
Experimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
干预措施: ultraHypofractionation (Radiation)
结局指标
主要结局
Rate of Acute grade 2 or higher toxicity (NCI-CTCAE)
时间窗: Start of treatment till 3 months from end of treatment
Each patient will be assessed weekly during radiotherapy and monthly for three months post radiotherapy to assess acute toxicity and will be documented according to Common Terminology Criteria for adverse events (CTCAE)
Rate of chronic Toxicity grade 2 or higher (NCI-CTCAE)
时间窗: Before start treatment and from 6 months after finishing treatment every 6 months up to average 2 years
Each patient will be assessed before treatment and at 6 , 12 , 24 months for chronic toxicity Criteria for adverse events (CTCAE)
Rate of Ipsilateral local tumor recurrence
时间窗: 1 to 2 years
Local recurrence proved by image and biopsy
Compliance to treatment (number of interrupted days of radiation)
时间窗: Start treatment till end of treatment (2 weeks in arm one and 3 weeks in arm2)
Treatment interruptions of planned cycles
次要结局
- Overall survival(From date of diagnosis up to average 2 years)