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Stereotactic Magnetic Resonance Guided Radiation Therapy

ConditionsPancreas CancerLung CancerRenal CancerAdrenal MetastasesProstate CancerLiver MetastasesOligoprogressive Nodal MetastasesMetachronous Nodal MetastasesSynchronous Nodal MetastasesMesotheliomaSpine MetastasesBrain MetastasesBorderline Resectable Pancreatic Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Specific exclusion requirements for each disease site with be covered in each specific cohort

History of allergic reactions attributed to gadolinium-based IV contrast.

Pregnant women are excluded from this study.

Severe claustrophobia or anxiety

Trial design

Design model

Parallel

Treatments tested in this trial

  • MR-guided Linac

    Radiation

    Radiation will be delivered on an MR-guided Linear Accelerator

Treatment groups

397 Participants
are divided into 19 treatment groups

19

Treatment groups

See each treatment group below.

Group A: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--PancreaticExperimental treatment 1 intervention
Group B: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--RenalExperimental treatment 1 intervention
Group C: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central LungExperimental treatment 1 intervention
Group D: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal MetastasesExperimental treatment 1 intervention
Group E: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver MetastasesExperimental treatment 1 intervention
Group F: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic NodesExperimental treatment 1 intervention
Group G: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft TissueExperimental treatment 1 intervention
Group H: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft TissueExperimental treatment 1 intervention
Group I: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--ProstateExperimental treatment 1 intervention
Group J: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable PancreasExperimental treatment 1 intervention
Group K: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain MetastasesExperimental treatment 1 intervention
Group L: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--MesotheliomaExperimental treatment 1 intervention
Group M: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate BoostExperimental treatment 1 intervention
Group N: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-IrradiationExperimental treatment 1 intervention
Group O: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--SpineExperimental treatment 1 intervention
Group P: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney TumorsExperimental treatment 1 intervention
Group Q: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/PelvisExperimental treatment 1 intervention
Group R: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung CancerExperimental treatment 1 intervention
Group S: PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph NodesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Delivery Success Rate for SMART across multiple tumors-Phase I

Enrolling patients and delivering SMART on the MR Linac

Time frame
1 year
2

Tumor visualization-Phase I

Assessing tumor using MR guidance before, during and after MR-guided treatment patient

Time frame
1 Year
3

Plan creation-Phase I

Generating adaptive plans

Time frame
1 Year
4

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.

Time frame
1 Year

Secondary outcomes

1

Number of Patients with Acute Toxicity-Phase I

Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART

Time frame
90 Days
2

Duration of treatment-Phase 1

Duration of treatment with goal of \>80% of cases treated within 90 minutes

Time frame
90 Days
3

Number of treatment fractions-Phase1

Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART

Time frame
90 Days
4

Number of Participants with long term toxicity-Phase II

assessing long-term (12 month) toxicity in patients receiving SMART

Time frame
365 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Source ClinicalTrials.gov
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