This prospective, open-label, Phase I/II, clinical trial is feasibility study to evaluate
MR-guided radiotherapy with the Alberta linac-MR P3 system in adult patients with cancer that
are treated with external beam radiotherapy in four graduated stages (described below),
progressing from palliative participants with simple techniques to curative participants with
complex techniques, with progression to each stage determined by an internal SAFE review
committee. Conventional treatment margins and doses will be utilized, with the MR being
utilized in place of CT based imaging. The intent is to replicate current CT based treatments
on the Alberta linac-MR P3 system using MR guided imaging, planning and treatment delivery.
MR imaging will be utilized for simulation, planning and image guidance. Dosimetry will be
done as per standard of care. MRI contrast may be used, as applicable. Adverse events will be
collected weekly during RT, and participants will complete one questionnaire at the end of
their RT treatment. Follow-up will consist of adverse event assessment at 1, 3, 6, and 12
months following completion of RT, and may be assessed annually via chart review for up to 5
years. Survival status will be assessed at 12 months following completion of RT, and then
annually for up to 5 years.
In stage 1, 10 to 28 participants with incurable malignancies that require palliative
radiotherapy with parallel-opposed pair beam arrangements will be enrolled. These will be
patients with bone or brain metastases from their malignancies that require either a single
fraction or multiple fractions of radiotherapy. The treatment will be a simple opposed pair
beam arrangement to a dose of a single 8 Gy or to a dose of 20 Gy over a course of 5
fractions. Once some initial treatments are completed, and at the discretion of an internal
SAFE review committee, additional treatment sites will be permitted (i.e. lung, abdomen,
etc.) that are also utilizing a simple opposed pair beam arrangement with the above doses.
In stage 2, 10 to 28 participants with malignancies (curative or palliative treatments) that
require multi-field arrangement for their external beam radiotherapy will be enrolled.
Initially, 4 field techniques (anterior, posterior, right lateral, left lateral) will be
utilized to treat central tumors using fractionation schemes that are currently considered
standard of care. Patients with pelvic malignancies (i.e. rectal cancers, cervical cancers,
endometrial cancers) or other malignancies requiring simple four field techniques will be
identified for this stage. As well, breast patients requiring a simple tangential opposed
pair beam arrangement or 3 - 4 field technique (to include the supraclavicular nodal regions)
will be enrolled, with preference for standard hypofractionation schedules, if possible.
In stage 3, 10 to 28 participants with malignancies (primarily curable, but incurable
malignancies may also be considered) that require more complicated multi-field 3DCRT
treatments (not requiring IMRT) for their external beam radiotherapy (i.e. lung, brain, etc.)
will be enrolled. This will include the use of field-in-field techniques such as
step-and-shoot techniques to allow for modulation of the radiation beam during treatment.
In stage 4, 10 to 28 participants with malignancies (primarily curable, but incurable
malignancies may also be considered) that require more complicated multi-field IMRT
treatments for their external beam radiotherapy (i.e. prostate, head and neck, lung, brain,
etc.) will be enrolled.