Stereotactic Magnetic Resonance Guided Radiation Therapy

Prostate Cancer Clinical Trial

Official title:

A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04115254
• Other study ID #: 19-353
• Status: Suspended
• Phase: N/A
• Start date: October 22, 2019
• Est. completion date: June 2024

Study information

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

Clinical Trial Summary

This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.

• The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer.

• Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures

Description:

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 to treat cancer.

The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer.

In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 397
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details.

• Tumor size = 7cm

• 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.

• Specific eligibility requirements for each disease site with be covered in each specific cohort.

Exclusion Criteria:

• Specific exclusion requirements for each disease site with be covered in each specific cohort

• History of allergic reactions attributed to gadolinium-based IV contrast.

-- Note: If a patient will not receive contrast, this is not applicable

• Pregnant women are excluded from this study.

• Severe claustrophobia or anxiety

• Participants who cannot undergo an MRI

Related Conditions & MeSH terms

• Adrenal Metastases
• Borderline Resectable Pancreatic Carcinoma
• Brain Metastases
• Brain Neoplasms
• Carcinoma, Renal Cell
• Kidney Neoplasms
• Liver Metastases
• Lung Cancer
• Mesothelioma
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Pancreas Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Prostatic Neoplasms
• Renal Cancer
• Spine Metastases

Intervention

Radiation:
• MR-guided Linac
Radiation will be delivered on an MR-guided Linear Accelerator

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	Delivery Success Rate for SMART across multiple tumors-Phase I	Enrolling patients and delivering SMART on the MR Linac	1 year
Primary	Tumor visualization-Phase I	Assessing tumor using MR guidance before, during and after MR-guided treatment patient	1 Year
Primary	Plan creation-Phase I	Generating adaptive plans	1 Year
Primary	Rate of Improvement in Tumor Control-Phase II	Statistical power will be defined in each cohort individually and will be specific to each disease site tested.	1 Year
Secondary	Number of Patients with Acute Toxicity-Phase I	Any related = Grade 3 AE which is possibly, probably or definitely related to SMART	90 Days
Secondary	Duration of treatment-Phase 1	Duration of treatment with goal of >80% of cases treated within 90 minutes	90 Days
Secondary	Number of treatment fractions-Phase1	Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART	90 Days
Secondary	Number of Participants with long term toxicity-Phase II	assessing long-term (12 month) toxicity in patients receiving SMART	365 Days
Secondary	Disease Specific Survival Rate-Phase II	Kaplan-Meier curve estimates	365 Days
Secondary	Overall Survival Rate-Phase II	Kaplan-Meier curve estimates	365