Menu
Recruiting NCT04115254

Stereotactic Magnetic Resonance Guided Radiation Therapy

No phase Interventional Pancreas Cancer Lung Cancer Renal Cancer Adrenal Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MR-guided Linac.
Who it may be relevant to
Registry conditions: Pancreas Cancer, Lung Cancer, Renal Cancer, Adrenal Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)

Overview

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

Detailed 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.

Interventions

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

Primary outcome measures

  • Delivery Success Rate for SMART across multiple tumors-Phase I [Time frame: 1 year]
  • Tumor visualization-Phase I [Time frame: 1 Year]
  • Plan creation-Phase I [Time frame: 1 Year]
  • Rate of Improvement in Tumor Control-Phase II [Time frame: 1 Year]
Secondary outcome measures (6)
  • Number of Patients with Acute Toxicity-Phase I [Time frame: 90 Days]
  • Duration of treatment-Phase 1 [Time frame: 90 Days]
  • Number of treatment fractions-Phase1 [Time frame: 90 Days]
  • Number of Participants with long term toxicity-Phase II [Time frame: 365 Days]
  • Disease Specific Survival Rate-Phase II [Time frame: 365 Days]
  • Overall Survival Rate-Phase II [Time frame: 365]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Brigham & Women's Hospital — Boston
  • Dana Farber Cancer Institute — Boston

Publications

  • Leeman JE, Shin KY, Droznin A, Catalano P, Cagney DN, Singer L, Oniyangi RD, Zhai K, Benham G, Chirmade S, Campbell J, Boyle S, Saranteas A, Williams CL, Huynh E, Han Z, Sudhyadhom A, Hu YH, Ferguson D, Singhrao K, Hsu SH, Bredfeldt J, Martin NE, Mancias JD, Mamon HJ, Van Dams R, Venkatachalam V, Tanguturi SK, Huynh MA, Fitzgerald KJ, Elhalawani H, Bitterman DS, Schoenfeld JD, Nguyen P, Haas-Kogan PMID 40794880

Identifiers

NCT: NCT04115254 · 19-353

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗