Clinical trial NCT04368702: CONFIRM: Magnetic Resonance Guided Radiation Therapy
Official title: Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Invasive Breast Cancer
in Situ Breast Cancer
Mantle Cell Lymphoma
Larynx Cancer
Bladder Cancer
Keywords: Gastric Cancer
Invasive Breast Cancer
in Situ Breast Cancer
Lymphoma
Larynx
Bladder
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Number of Patients and delivering MR-image guided radiation-Phase I
timeFrame: 5 weeks
measure: Tumor Assessment with MR Guidance-Phase I
timeFrame: 5 weeks
measure: Patient reported outcomes (PROMs) -Phase II
timeFrame: 1 year
measure: 1-year tumor control-Phase II
timeFrame: 1 year
measure: Rate of Pathologic complete response-Gastric
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
timeFrame: 90 Days
measure: Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
timeFrame: 1 year
measure: Duration of treatment with goal of >80% of cases treated within 90 minutes
timeFrame: 7 weeks
measure: Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without MR-image guided radiation.
timeFrame: 5 Weeks
measure: Progression Free Survival
timeFrame: 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
measure: Overall Survival
timeFrame: 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
measure: Characterizing MRI-based tumor alterations/changes following MR-image guided radiation
timeFrame: 1 Year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Raymond Mak, MD
role: PRINCIPAL_INVESTIGATOR
References: