CONFIRM: Magnetic Resonance Guided Radiation Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Viewray MRIdian® Linac.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Mantle Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol
Overview
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.
Detailed description
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.
This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation. Investigators at other hospitals and academic centers are already using this type of radiation.
The U.S. Food and Drug Administration (FDA) has approved this radiation machine and these drugs as treatment options for gastric and breast cancer.
Interventions
- Radiation Viewray MRIdian® Linac
MR-image guided radiation will be administered per disease site standards.
Primary outcome measures
- Number of Patients and delivering MR-image guided radiation-Phase I [Time frame: 5 weeks]
- Tumor Assessment with MR Guidance-Phase I [Time frame: 5 weeks]
- Patient reported outcomes (PROMs) -Phase II [Time frame: 1 year]
- 1-year tumor control-Phase II [Time frame: 1 year]
- Rate of Pathologic complete response-Gastric [Time frame: 1 year]
Secondary outcome measures (7)
- Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0. [Time frame: 90 Days]
- Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0. [Time frame: 1 year]
- Duration of treatment with goal of >80% of cases treated within 90 minutes [Time frame: 7 weeks]
- Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without MR-image guided radiation. [Time frame: 5 Weeks]
- Progression Free Survival [Time frame: 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 [Time frame: 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 [Time frame: 1 Year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Brigham & Women's Hospital — Boston
- Dana Farber Cancer Institute — Boston
Identifiers
NCT: NCT04368702 · 19-665