FRACTIONATE

Overview

About this study

All lesions 4.0 cm to 6.0 cm will receive 32.5 Gy/5 fractions and will be analyzed separately.  The portion of the trial is written as a phase II study without randomization noting the rarity of unresected brain metastasis of this size and the lack of comfort of treating radiation oncologist and neurosurgeons with single fraction SRS for tumors this large. However, noting the paucity of prospective data for this patient population enrolling patients on a clinical trial will provide a more accurate historical control for future trials.  Although this cohort was enrolled on the prospective phase I trial from Emory and the fractionation of 32.5 Gy in 5 fraction appeared safe and efficacious, a larger cohort of patients is needed to better evaluate the therapeutic ratio of this regimen for this patient population.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Age ≥ 18 years old
  • Diagnosis of Brain Metastases
    • Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.).
    • Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible.
  • Size of Brain Metastases
    • At least one intact metastasis (not previously treated with radiosurgery) must measure > 2.0 cm and < 4.0 cm in maximal extent on the contrasted pre-treatment MRI brain scan obtained ≤ 28 days prior to registration.
    • If the largest lesion measures ≥ 2.0 to < 4.0 cm in maximal extent the patient will be randomized.
  • Able to undergo contrast enhanced MRI Brain
  • Negative urine or serum pregnancy test completed ≤7 days prior to registration, for women of childbearing potential only
  • Patient willing and able to provide written informed consent
  • Karnofsky Performance Status (KPS) ≥ 50
  • ECOG Performance Score of (PS) ≥ 2
  • Past radiosurgery or resection is allowed as long as no definitive evidence of progression in these locations.
    • Note: Repeat radiosurgery to the same location/lesion is not allowed on this protocol.

Exclusion Criteria

  • Any patient who has received previous whole brain radiation
  • Any brain metastasis that is located in the brainstem measuring ≥ 2.0 cm in maximal extent.
  • Any patient with definitive evidence of leptomeningeal metastasis (LMD).

NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive CSF cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator’s discretion based on level of clinical suspicion.{Kim, 2017 #2840}

  • Any patient with an intact brain metastasis measuring > 4.0 cm

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paul Brown, M.D.

Closed-enrolling by invitation

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Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Ron Smith, M.D.

Closed-enrolling by invitation

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Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

La Crosse, Wis.

Mayo Clinic principal investigator

Abigail Stockham, M.D.

Closed-enrolling by invitation

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Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Jennifer Peterson, M.D.

Closed-enrolling by invitation

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Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Now Bahar Alam, M.D.

Closed-enrolling by invitation

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Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Sujay Vora, M.D.

Closed-enrolling by invitation

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Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Albert Lea, Minn.

Mayo Clinic principal investigator

John Yeakel, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

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Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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