减少剂量放射治疗惰性非霍奇金淋巴瘤
惰性非霍奇金淋巴瘤的减剂量大分割放射治疗（3Gy x 3 次）（POSEIDON）：多中心 2 期随机试验
This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma.
研究概览
地位
详细说明
PRIMARY OBJECTIVE:
I. To show that the experimental arm [9 gray (Gy) in 3 fractions, 8 Gy in 2 fractions, or 10 Gy in 5 fractions] has significantly reduced acute toxicity (grade ≥ 2 adverse events at least possibly related to radiation treatment within 14 days after the end of radiation treatment [according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0] compared to 24 Gy in 12 fractions.
SECONDARY OBJECTIVES:
I. To evaluate patient reported quality of life. II. To evaluate response rate. III. To evaluate local control rate. IV. To evaluate relapse-free survival.
EXPLORATORY OBJECTIVES:
I. Financial toxicity will be assessed at the end of radiation treatment. II. Financial health care expenditure will be assessed at the end of radiation treatment III. Late toxicity.
CORRELATIVE RESEARCH OBJECTIVES:
I. Biopsies of enrolled patients will be evaluated for pathological assessment of cellular and genetic mutations to correlate them with disease local relapse and radiation resistance.
II. Patients will have their baseline positron emission tomography (PET)/computed tomography (CT) scan undergo auto-segmentation to calculate the functional imaging 18-fluoro-deoxyglucose (FDG) metabolic tumor volume (MTV), total lesions glycolysis (TLG) and maximum standardized uptake volume (SUVmax) of the sites to be treated with involved-site radiation therapy (ISRT) using MIMvista platform to correlate it with disease local relapse and treatment response.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo reduced dose ISRT once daily (QD) over 3, 2, or 5 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.
ARM II: Patients undergo standard of care (SOC) radiation therapy QD over 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.
After completion of study treatment, patients are followed up at days 7 and 14, months 3 and 6, and then every 6 months for up to 2 years post-radiation therapy.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Clinical Trials Referral Office
- 电话号码：855-776-0015
- 邮箱：mayocliniccancerstudies@mayo.edu
学习地点
-
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Arizona
-
Scottsdale、Arizona、美国、85259
- 招聘中
- Mayo Clinic in Arizona
-
接触：
- Clinical Trials Referral Office
- 电话号码：855-776-0015
- 邮箱：mayocliniccancerstudies@mayo.edu
-
首席研究员：
- William G. Rule, MD
-
-
Florida
-
Jacksonville、Florida、美国、32224-9980
- 招聘中
- Mayo Clinic in Florida
-
接触：
- Clinical Trials Referral Office
- 电话号码：855-776-0015
- 邮箱：mayocliniccancerstudies@mayo.edu
-
首席研究员：
- Brad S. Hoppe, MD, MPH
-
-
Minnesota
-
Albert Lea、Minnesota、美国、56007
- 招聘中
- Mayo Clinic Health System in Albert Lea
-
接触：
- Clinical Trials Referral Office
- 电话号码：855-776-0015
- 邮箱：mayocliniccancerstudies@mayo.edu
-
首席研究员：
- John Yeakel, MD
-
Mankato、Minnesota、美国、56001
- 撤销
- Mayo Clinic Health System - Mankato
-
Rochester、Minnesota、美国、55905
- 招聘中
- Mayo Clinic in Rochester
-
接触：
- Clinical Trials Referral Office
- 电话号码：855-776-0015
- 邮箱：mayocliniccancerstudies@mayo.edu
-
首席研究员：
- Scott C. Lester, MD
-
-
Wisconsin
-
Eau Claire、Wisconsin、美国、54701
- 招聘中
- Mayo Clinic Health System-Eau Claire Clinic
-
接触：
- Clinical Trials Referral Office
- 电话号码：855-776-0015
- 邮箱：mayocliniccancerstudies@mayo.edu
-
首席研究员：
- Now Bahar Alam, MD
-
La Crosse、Wisconsin、美国、54601
- 招聘中
- Mayo Clinic Health System-Franciscan Healthcare
-
接触：
- Clinical Trials Referral Office
- 电话号码：855-776-0015
- 邮箱：mayocliniccancerstudies@mayo.edu
-
首席研究员：
- Abigail L. Stockham, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
-
Age ≥ 18 years
-
Histological confirmation of indolent B-cell lymphoma that can include any of the following:
- Follicular lymphoma (grade 1 or 2 or 3A)
- Marginal zone lymphoma (nodal or extranodal)
- Follicle center lymphoma
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Any stage disease
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Initial, refractory, or relapsed disease. If relapse involves the site to be treated there must be evidence of disease progression
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3
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Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
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Provide written informed consent
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Ability to complete questionnaire(s) by themselves or with assistance
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Willing to return to enrolling institution for follow-up visits (during the active monitoring phase of the study). Virtual visits can also be considered as an option for applicable items
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Confirmation from radiation oncologist of suitability to participate in study
Exclusion Criteria:
-
Any of the following:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
-
T-cell lymphoma
-
Receiving treatment for small and chronic lymphocytic lymphoma
-
Grade 3B follicular lymphoma
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ARM 1 (reduced dose ISRT)
Patients undergo reduced dose ISRT once daily (excluding weekends): 9 Gy delivered in 3 treatment fractions or 8 Gy in 2 fractions. At physician discretion, patients may receive 10 Gy in 5 fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up. |
Ancillary studies Undergo CT or PET/CT
其他名称：
Undergo PET/CT
其他名称：
Undergo endoscopy
其他名称：
Undergo ISRT in 3 fractions
其他名称：
|
|
有源比较器：ARM 2 (SOC ISRT)
Patients undergo standard of care (SOC) radiation therapy once daily (excluding weekends): 24 Gy in 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up. |
Ancillary studies Undergo CT or PET/CT
其他名称：
Undergo PET/CT
其他名称：
Undergo endoscopy
其他名称：
Undergo ISRT in 12 fractions
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of grade 2 or higher acute adverse events (AEs)
大体时间：Up to 14 days after radiation treatment
|
AEs will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Acute toxicity will be reported as a proportion calculated as the number of patients with acute toxicity divided by the total number of treatment patients. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2). |
Up to 14 days after radiation treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Response rate
大体时间：Up to 3 months after radiation treatment
|
Response rate will be defined as the proportion of patients displaying response (complete response or partial response) at 3 months post treatment. Complete response is defined as the disappearance of all signs of cancer in response to treatment. Partial response is defined decrease in the size of target lesions by ≥ 50%, with no increase in the size of any lesion and no appearance of new lesions. Treated patients who do not have a 3-month evaluation will be classified as a non-response. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2). |
Up to 3 months after radiation treatment
|
|
Time to progression rate
大体时间：Up to 24 months after radiation treatment
|
Local control will be defined as the number of days from end of radiation treatment until first local recurrence within 24 months post radiation treatment. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2). |
Up to 24 months after radiation treatment
|
|
Patient reported quality of life
大体时间：Up to 3 months after radiation treatment
|
Patient reported quality of life will be measured using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, a 13-item questionnaire answered on a scale of 1-5 where 1=Not at all and 5=Very much. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2). |
Up to 3 months after radiation treatment
|
合作者和调查者
赞助
调查人员
- 首席研究员：Brad S. Hoppe, MD, MPH、Mayo Clinic
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.