Stereotactic Magnetic Resonance Guided Radiation Therapy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04115254
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Oct 22, 2019
Status verified
Nov 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
397 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Delivery Success Rate for SMART across multiple tumors-Phase I [ Time Frame: 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham & Women's HospitalBostonMassachusetts02115
Jonathan Leeman, MD
Jonathan Leeman, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Jonathan Leeman, MD
Jonathan Leeman, MD (PRINCIPAL_INVESTIGATOR)

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Brigham & Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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