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临床试验 NCT01758445 针对乳腺癌，乳腺肿瘤，乳腺肿瘤，乳腺癌目前进行中（不再招募）。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Proton Radiation for Stage II/III Breast Cancer II期 220
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临床试验NCT01758445旨在研究治疗，主要针对乳腺癌，乳腺肿瘤，乳腺肿瘤，乳腺癌。这是一项II期 干预性研究试验，目前试验状态为进行中（不再招募）。试验始于2013年2月1日，计划招募220名患者。该研究由Proton Collaborative Group主导，预计于2032年1月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月4日。
简要概括
The purpose of this study is to look at the rates of acute and long term adverse events of postoperative proton radiotherapy for complex loco-regional irradiation in women with loco-regionally advanced breast cancer. This study specifically includes longitudinal follow up to assess the incidence of cardiac mortality and second malignant neoplasms at 10 and 15 years following proton therapy(PT).
详细描述
The proposed Phase II study is seeking to build clinical data as a continuation of the original dosimetric analysis published by Ares et al. performed at Paul-Scherrer Institute (PSI). That comparison demonstrated a benefit form proton planning for patients with non-metastatic breast cancer requiring complex, loco-regional, postoperative radiotherapy.1 The advantages of PT were improved target coverage compared to st...显示更多
官方标题
Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Patients With Stage II/III,Loco-Regional, Non-Metastatic Breast Cancer Requiring Whole Breast or Chest Wall Irradiation With Lymph Node Irradiation
疾病
乳腺癌乳腺肿瘤乳腺肿瘤乳腺癌其他研究标识符
- BRE008-12
NCT编号
实际开始日期
2013-02
最近更新发布
2025-09-04
预计完成日期
2032-01
计划入组人数
220
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
进行中（不再招募）
关键词
Breast
Cancer
Radiation
Proton
Cancer
Radiation
Proton
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Proton Radiotherapy Proton Radiotherapy | 质子放疗 Radiation therapy will be given once a day. Minimum of 28 treatments and may receive 6-9 additional treatments as determined by protocol \& physician. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment. | 5 years |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Compare dosimetrically the dose volume histogram (DVH) of the PT plans with conventional external beam plans (either photon/electron intensity modulated radiotherapy(IMRT)plans, 3D-photon plans, or Tomotherapy plans). | On average at 9 weeks post start of treatment | |
Incidence rates of local control, regional control, metastatic status and disease free overall survival. | 5 years | |
Compare the different DVH parameters for the targets (D2, Dmean, Dmin, D95, V95, V110) and different OARs (as described later) of the PT plans with the corresponding values of the 3D-conformal radiation therapy (CRT), IMRT and Tomotherapy plans. | On average at 9 weeks post start of treatment | |
Determine dose distribution of proton therapy to coronary arteries, heart, ipsilateral and contralateral lung, and contralateral breast. | On average at 9 weeks post start of treatment | |
Determine the incidence of clinically symptomatic coronary artery disease, cardiac morbidity and mortality in general and incidence of secondary malignancy, including contralateral breast cancer | 5 years | |
Evaluate quality of life results. | 5 years |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
- Must be > = 18 years of age.
- Must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer.
- Must have pathology proven breast cancer. Pathology must be invasive ductal or lobular
- Must meet stage II - III group criteria per AJCC Staging manual 7th edition.
- Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted.
- Note: Multicentric breast cancer and Paget's disease of the nipple are permitted.
- Weight over 410 pounds.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible).
- Breast size exceeding the technical limitation of daily set-up reproducibility. This may be center-specific and will be assessed at the discretion of the treating center.
- Women with post-surgical temporary breast expanders will require individual assessment. Depending on the manufacturing product and other treatment planning-specific details the patient may be eligible or may be deemed ineligible, as determined by treating investigator.
- Prior history of breast cancer.
- Prior radiation to the breast or thorax.
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Pregnancy or lactation at the time of proposed study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide. (Note: Women of childbearing potential must have a negative serum pregnancy test within 3 weeks of study registration).
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
- Prior history of non-breast malignancies unless they have been disease free for 5 or more years and are deemed by their physician to be at low risk for recurrence. Further, patients who have the following cancers treated within the prior 5 years are permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell or squamous cell carcinoma of the skin.
Proton Collaborative Group没有联系数据。
5 位于 1 个国家/地区的研究中心
Illinois
Northwestern Medicine Chicago Proton Center, Warrenville, Illinois, 60555, United States
Maryland
Maryland Proton Treatment Center, Baltimore, Maryland, 21201, United States
New Jersey
Princeton ProCure Managment LLC, Somerset, New Jersey, 08873, United States
Oklahoma
Oklahoma Proton Center, Oklahoma City, Oklahoma, 73142, United States
Virginia
Hampton University Proton Therapy Institute, Hampton, Virginia, 23666, United States