2019-10-22
2028-06
2028-06
397
NCT04115254
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
INTERVENTIONAL
Stereotactic Magnetic Resonance Guided Radiation Therapy
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
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-09-26 | N/A | 2024-11-04 |
2019-10-02 | N/A | 2024-11-05 |
2019-10-03 | N/A | 2024-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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 | RADIATION: MR-guided Linac
|
| 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 | RADIATION: MR-guided Linac
|
| 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 | RADIATION: MR-guided Linac
|
| 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 Measures | Measure Description | Time Frame |
|---|---|---|
| Delivery Success Rate for SMART across multiple tumors-Phase I | Enrolling patients and delivering SMART on the MR Linac | 1 year |
| Tumor visualization-Phase I | Assessing tumor using MR guidance before, during and after MR-guided treatment patient | 1 Year |
| Plan creation-Phase I | Generating adaptive plans | 1 Year |
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Patients with Acute Toxicity-Phase I | Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART | 90 Days |
| Duration of treatment-Phase 1 | Duration of treatment with goal of >80% of cases treated within 90 minutes | 90 Days |
| 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 |
| Number of Participants with long term toxicity-Phase II | assessing long-term (12 month) toxicity in patients receiving SMART | 365 Days |
| Disease Specific Survival Rate-Phase II | Kaplan-Meier curve estimates | 365 Days |
| Overall Survival Rate-Phase II | Kaplan-Meier curve estimates | 365 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jonathan Leeman, MD Phone Number: 617-732-6452 Email: JONATHANE_LEEMAN@DFCI.HARVARD.EDU |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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