MC230808 Reduced Dose Hypofractionated Radiotherapy (3Gy x 3 Fractions) for Indolent Non-Hodgkin Lymphoma (POSEIDON): A Multisite Phase 2 Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 112
- 试验地点
- 14
- 主要终点
- Incidence of grade 2 or higher acute adverse events (AEs)
研究概览
简要总结
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.
详细描述
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:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Any stage disease
- •Initial, refractory, or relapsed disease. If relapse involves the site to be treated there must be evidence of disease progression
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3
- •Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
- •Provide written informed consent
- •Ability to complete questionnaire(s) by themselves or with assistance
- •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
- •Confirmation from radiation oncologist of suitability to participate in study
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Computed Tomography (Procedure)
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.
干预措施: Endoscopic Procedure (Procedure)
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.
干预措施: Involved-site Radiation Therapy (3 Fractions) (Radiation)
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.
干预措施: Positron Emission Tomography (Procedure)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Computed Tomography (Procedure)
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.
干预措施: Endoscopic Procedure (Procedure)
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.
干预措施: Involved-site Radiation Therapy (12 Fractions) (Radiation)
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.
干预措施: Positron Emission Tomography (Procedure)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Incidence of grade 2 or higher acute adverse events (AEs)
时间窗: 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).
次要结局
- Response rate(Up to 3 months after radiation treatment)
- Time to progression rate(Up to 24 months after radiation treatment)
- Patient reported quality of life(Up to 3 months after radiation treatment)