CONFIRM: MR-Guided Radiation Therapy for Gastric and Breast Cancer
This study, called CONFIRM, is looking at how safe and practical it is to use a special type of radiation therapy guided by magnetic resonance imaging (MRI) for people with gastric (stomach) cancer or breast cancer. The treatment uses a machine called the Viewray MRIdian® Linac. Doctors hope that using MRI during radiation will help them target the cancer more precisely. The study will measure how many patients can receive this treatment and how well it works on tumors. We will also ask about your experiences and well-being for up to one year. This is a Phase I/II study, meaning it's testing the safety of this new way of delivering radiation and finding the right dose. The study aims to enroll 70 participants aged 18 or older who have cancer requiring radiation.
- Study design
- This is a Phase I/II interventional study, meaning it tests a new treatment approach. It plans to include 70 participants.
- What's involved
- You would go through screening, receive study treatment with evaluations, attend follow-up visits, and complete questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your well-being will be assessed for up to one year after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CONFIRM: Magnetic Resonance Guided Radiation Therapy
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Raymond Mak, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of Patients and delivering MR-image guided radiation-Phase I5 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
- Tumor Assessment with MR Guidance-Phase I5 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 II1 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 II1 year
Tumor response 1 year after radiation treatment
- Rate of Pathologic complete response-Gastric1 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.