Stereotactic Magnetic Resonance Guided Radiation Therapy

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Synchronous Nodal Metastases; Brain Metastases; Liver Metastases; Lung Cancer; Pancreas Cancer; Spine Metastases; Metachronous Nodal Metastases; Oligoprogressive Nodal Metastases; Borderline Resectable Pancreatic Carcinoma; Renal Cancer; Mesothelioma; Adrenal Metastases; Prostate Cancer

Treatments: Radiation: MR-guided Linac

Study type: Interventional

Funder types: Other

Identifiers

NCT04115254

19-353

Details and patient eligibility

About

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

Full 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.

Enrollment: 397 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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397 participants in 19 patient groups

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes

Experimental group

Description:

SMART will be administered per each individual disease site standards

Treatment:

Radiation: MR-guided Linac