A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)
Who is this study for? Patients with cancer
What treatments are being studied? MR-guided Linac
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Massachusetts
Brigham & Women's Hospital
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Jonathan Leeman, MD
JONATHANE_LEEMAN@DFCI.HARVARD.EDU
617-732-6452
Time Frame
Start Date: 2019-10-22
Estimated Completion Date: 2028-06
Participants
Target number of participants: 397
Treatments
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
Authors
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute