Stereotactic Magnetic Resonance Guided Radiation Therapy

Not Applicable

Recruiting

• Conditions: Lung Cancer; Renal Cancer; Prostate Cancer; Liver Metastases; Mesothelioma; Spine Metastases; Pancreas Cancer; Borderline Resectable Pancreatic Carcinoma; Adrenal Metastases; Brain Metastases
• Interventions: Radiation: MR-guided Linac

• Registration Number: NCT04115254
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-03
• Study Start: 2019-10-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 397

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors	MR-guided Linac	SMART will be administered per each individual disease site standards
PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes	MR-guided Linac	SMART will be administered per each individual disease site standards

Primary Outcome Measures

Name	Time	Method
Plan creation-Phase I	1 Year	Generating adaptive plans
Delivery Success Rate for SMART across multiple tumors-Phase I	1 year	Enrolling patients and delivering SMART on the MR Linac
Tumor visualization-Phase I	1 Year	Assessing tumor using MR guidance before, during and after MR-guided treatment patient
Rate of Improvement in Tumor Control-Phase II	1 Year	Statistical power will be defined in each cohort individually and will be specific to each disease site tested.

Secondary Outcome Measures

Name	Time	Method
Overall Survival Rate-Phase II	365	Kaplan-Meier curve estimates
Number of Patients with Acute Toxicity-Phase I	90 Days	Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART
Number of Participants with long term toxicity-Phase II	365 Days	assessing long-term (12 month) toxicity in patients receiving SMART
Disease Specific Survival Rate-Phase II	365 Days	Kaplan-Meier curve estimates
Duration of treatment-Phase 1	90 Days	Duration of treatment with goal of \>80% of cases treated within 90 minutes
Number of treatment fractions-Phase1	90 Days	Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART

Trial Locations

Locations (2)

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States