Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Tumor Assessment with MR Guidance-Phase I
研究概览
简要总结
This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.
详细描述
This is a master clinical protocol evaluating magnetic resonance (MR) image guided radiation in patients with gastric and breast cancer.
In this research study, the investigators are researching if getting an MRI during radiation is a feasible way to delivery radiation. In this research study, a MRI done during treatment will help doctors adapt the radiation to target the most precise spot where the cancer is located.
The research study procedures include:
- Screening for eligibility
- Study treatment including evaluations
- Follow up visits
- Questionnaires
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of investigational radiation treatment and also tries to define the appropriate dose of the investigational radiation treatment to use for further studies. "Investigational" means that the way the radiation treatment is delivered is being studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Participants must have histologically or cytologically confirmed malignancy requiring radiation
- •Age 18 years of older
- •ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- •Ability to understand and the willingness to sign a written informed consent document.
- •Any further criteria listed in the specific disease site cohort
排除标准
- •History of allergic reactions attributed to gadolinium-based IV contrast
- •-- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility
- •Severe claustrophobia or anxiety
- •Participants who cannot undergo an MRI
- •Any other exclusion criteria listed in the specific disease site cohort
研究组 & 干预措施
Phase I - Gastric Cancer
The research study procedures include:
- Screening for eligibility
- Study treatment including evaluations
- MR-image guided radiation will be administered per disease site standards.
- Follow up visits
- Questionnaires
干预措施: Viewray MRIdian® Linac (Radiation)
Phase I - Breast Cancer
The research study procedures include:
- Screening for eligibility
- Study treatment including evaluations
- MR-image guided radiation will be administered per disease site standards.
- Follow up visits
- Questionnaires
干预措施: Viewray MRIdian® Linac (Radiation)
Phase I - Mantle Cell Lymphoma
The research study procedures include:
- Screening for eligibility
- Study treatment including evaluations
- MR-image guided radiation will be administered per disease site standards.
- Follow up visits
- Questionnaires
干预措施: Viewray MRIdian® Linac (Radiation)
Phase I - Larynx
The research study procedures include:
- Screening for eligibility
- Study treatment including evaluations
- MR-image guided radiation will be administered per disease site standards.
- Follow up visits
- Questionnaires
干预措施: Viewray MRIdian® Linac (Radiation)
Phase I - Bladder
The research study procedures include:
- Screening for eligibility
- Study treatment including evaluations
- MR-image guided radiation will be administered per disease site standards.
- Follow up visits
- Questionnaires
干预措施: Viewray MRIdian® Linac (Radiation)
结局指标
主要结局
Tumor Assessment with MR Guidance-Phase I
时间窗: 5 weeks
Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as assessing tumor using MR guidance before, during and after MR-guided treatment patient.
Patient reported outcomes (PROMs) -Phase II
时间窗: 1 year
PROMs are collected at patient visits. PROMs will be evaluated using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS Global-10 metric collects information on symptoms and quality of life.
1-year tumor control-Phase II
时间窗: 1 year
Tumor response 1 year after radiation treatment
Number of Patients and delivering MR-image guided radiation-Phase I
时间窗: 5 weeks
Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as Enrolling patients and delivering MR-image guided radiation on the MR Linac
Rate of Pathologic complete response-Gastric
时间窗: 1 year
full pathological review of surgical specimen according to the AJCC Staging Classification, 8th edition. pCR will be defined as the absence of any viable tumor cells within the pathologic specimen.
次要结局
- Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.(1 year)
- Duration of treatment with goal of >80% of cases treated within 90 minutes(7 weeks)
- Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without MR-image guided radiation.(5 Weeks)
- Progression Free Survival(irst date of protocol therapy to the earliest date of disease progression per RECIST criteria or death due to any cause up to 12 Months)
- Overall Survival(irst date of protocol therapy to the date of death due to any cause. OS time will be censored at the date of last follow-up for patients still alive up to 1 year)
- Characterizing MRI-based tumor alterations/changes following MR-image guided radiation(1 Year)
- Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.(90 Days)
研究者
Raymond Mak
Principal Investigator
Brigham and Women's Hospital