CONFIRM: Magnetic Resonance Guided Radiation Therapy

Gastric Cancer Clinical Trial

— CONFIRM  

Official title:

Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04368702
• Other study ID #: 19-665
• Status: Suspended
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: June 18, 2024

Study information

• Verified date: November 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 70
• Est. completion date: June 18, 2024
• Est. primary completion date: June 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Carcinoma In Situ
• Breast Neoplasms
• Gastric Cancer
• in Situ Breast Cancer
• Invasive Breast Cancer
• Laryngeal Neoplasms
• Larynx Cancer
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma
• Stomach Neoplasms

Intervention

Radiation:
• Viewray MRIdian® Linac
MR-image guided radiation will be administered per disease site standards.

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients and delivering MR-image guided radiation-Phase I	Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as Enrolling patients and delivering MR-image guided radiation on the MR Linac	5 weeks
Primary	Tumor Assessment with MR Guidance-Phase I	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.	5 weeks
Primary	Patient reported outcomes (PROMs) -Phase II	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
Primary	1-year tumor control-Phase II	Tumor response 1 year after radiation treatment	1 year
Primary	Rate of Pathologic complete response-Gastric	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.	1 year
Secondary	Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.	Toxicity of MRgRT with concurrent chemotherapy will be summarized by category and grade according to CTCAE version 5.0.	90 Days
Secondary	Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.	CTCAE version 5.0.	1 year
Secondary	Duration of treatment with goal of >80% of cases treated within 90 minutes	Total time of treatment for each fraction	7 weeks
Secondary	Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without MR-image guided radiation.	Importance of MR-guidance	5 Weeks
Secondary	Progression Free Survival	Estimated using the Kaplan Meier method with 95% confidence intervals based on the complementary log-log transformation.	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
Secondary	Overall Survival	The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.	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
Secondary	Characterizing MRI-based tumor alterations/changes following MR-image guided radiation	Evaluation of tumor response following treatment	1 Year