NCT03127995进行中（未招募）不适用
Multicenter Randomized Phase III Trial Comparing Hypofractionated Versus Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation in Terms of Lymphedema Occurrence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 1,265
- 试验地点
- 39
- 主要终点
- Arm Lymphedema
研究概览
简要总结
The standard treatment of localized breast cancers consists of surgical removal of the tumor at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or thoracic wall and the lymph node areas from 5 to 6.5 weeks.
Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement have been equally effective and have no more side effects in several clinical trials involving several thousand patients. This called hypofractionated radiotherapy has become a standard for breast cancers in the absence of lymph node involvement in postmenopausal women.
The objective of the HypoG01 trial is to evaluate hypofractionated radiotherapy in women who require radiotherapy in the breast or chest wall and lymph node areas by comparing standard over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side effects and in particular the risk of lymphedema (swelling of the arm on the side treated) and the effectiveness of these treatments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman ≥ 18 years who had radical surgery for invasive breast cancer pT1-3, pN0-N3, M0 with either mastectomy or breast conservation. The patient can be included no matter the status of oestrogen receptor, progesterone receptor, malignancy grade, HER2 status.
- •Axillary lymph node dissection of the axilla where the findings give indication for regional nodes radiotherapy to levels +/-I, +/- II, +/-III, +/-IV, +/-interpectoral nodes (Rötter) and +/-the IMN.
- •Sentinel node biopsy documenting limited nodal disease without an indication for axillary lymph node dissection according to institutional, national or other trial guidelines are accepted.
- •The patient may be a candidate for a boost to the tumour bed.
- •Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
- •Neoadjuvant chemotherapy for downstaging according to institutional or national guidelines is accepted if there is not an indication for a boost in the area of regional nodes after surgery.
- •Primary systemic therapy of an operable breast cancer is accepted.
- •If the patient is not treated with chemotherapy, the patient must be randomized within 8 weeks from last surgery. If the patient has received adjuvant chemotherapy, the patient must be randomized within 4 weeks after the last series of adjuvant chemotherapy or within 42 days from last surgery in case of surgery after neoadjuvant or adjuvant chemotherapy.Breast implants are accepted.
- •Connective tissue disease is allowed if the treating radiation oncologist finds radiotherapy indicated
- •Postoperative infection and/or seroma giving indication for drainage during RT is accepted
- •Women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy
- •Signed informed consent
- •Affiliated to the Social Security system
排除标准
- •Previous breast cancer or DCIS of the breast.
- •Bilateral breast cancer
- •Patient with previous non-breast malignancy with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- •The patient has an indication for boost to 1 or more regional nodes
- •Previous radiotherapy to the chest region
- •Patient enrolled in another therapeutic trial. Observational cohorts are accepted if the collection of data does not interfere with the current trial
- •Pregnant or lactating
- •Conditions indicating that the patient cannot go through the radiation therapy or follow up, or a condition where the treating radiation oncologist thinks the patient should not participate in the trial for example due to language problems.
结局指标
主要结局
Arm Lymphedema
时间窗: At 3 years
Occurrence radiation-induced late morbidity measured as lymphedema of the arm on the treated side at 3 years after adjuvant radiotherapy as follows: At least≥ 10% increased arm circumference measured 15 cm proximal and/or 10 cm distal of the olecranon of the treated side relative to the baseline value, compared to the contralateral side circumference also relative to its baseline value.
次要结局
- Aesthetics Assessment-BIS SCORE(Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years)
- CTCAE Toxicity Assessment(Before treatment, every week of treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years)
- Cancer Related events(6 months after the last fraction received, every year during 5 years, 10 years)
- Quality of Life EORTC BR23(Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years)
- Functional Assessment(Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years)
- Aesthetics Assessment-FIBROSIS(Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years)
- Aesthetics Assessment-Global Cosmestic(Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years)
- RTOG/EORTC Toxicity Assessment(Before treatment, every week of treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years)
- Cost-Utility(Week 3 or week 7 of treatment according the treatment arm and boost realization)
- Quality of Life QLQ-C30(Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years)
- Quality of Life Euroqol EQ-5D5D(Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years)
研究者
研究点 (39)
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