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Completed

NCT Number: NCT02054689

Fractionated Stereotactic Radiosurgery for Large Brain Metastases

This is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and possible costs will be described later in this document. This clinical trial is for people who have had no prior whole brain radiation.

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Key information

Conditions

Large Brain Mets

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Shadyside Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients ≥ 18 years of age
  • A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix II)
  • The target lesion(s) can be accurately measured in at least one dimension according to RECIST
  • No prior radiotherapy to the brain
  • Previous or concurrent systemic or targeted chemotherapy is allowed
  • Patients must have an extra-cranial primary tumor diagnosis
  • Patients will have no more than 3 distinct lesions within the brain. At least 1 lesion must be a minimum of 3cm in greatest dimension, no larger than 5cm which will be treatable by fractionated stereotactic radiosurgery
  • The additional lesions will each be treated with single fraction stereotactic radiosurgery
  • Patient may be on steroids or anti-epileptics
  • Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
  • Patients do not need a histologically proven diagnosis of brain mets

Exclusion criteria

  • Symptomatic patients in need of surgery to the "target" lesion
  • Four or more newly-diagnosed lesions
  • Prior surgical resection of targeted tumor
  • Prior WBRT
  • Primary brain tumor
  • Pregnant or breast-feeding patients
  • Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor

Treatment and study plan

Fractionated Stereotactic Radiosurgery

Radiation

SRS SBRT CyberKnife Trilogy True Beam Radiosurgery

Other names: SRS, SBRT, CyberKnife, Trilogy, True Beam, Radiosurgery

Primary outcomes

  1. Number of Patients Experiencing DLT

    Time frame: Up to 3 years

    The number of patients experiencing DLT, defined as the maximum amount of Gy fractionated stereotactic radiosurgery (FSRS) delivered without significant toxicity.

  2. Maximum Tolerated Dose (MTD)

    Time frame: Up to 24 months post completion of treatment

    The MTD was determined following a Time-to-Event Continual Reassessment Model which models toxicity as a function of dose. Treatment was given in 3 fractions (8-12 Gy/fx).

Secondary outcomes

  1. Best Response

    Time frame: Up to 24 months after completion of treatment

    Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) in the target lesion, or Progressive Disease (PD) per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

  2. Local Control of Disease

    Time frame: Up to 24 months after completion of treatment

    Percentage of patients with local control, defined as stable disease (SD), partial response (PR), or complete response (CR) in the target lesion, per RECIST v1.1. Complete Response (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm., Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

  3. Regional Intracranial Failure

    Time frame: Up to 24 months after completion of treatment

    Percentage of patients who develop new lesions outside the target volume. Patients without follow-up scans are excluded as it is not known if they developed lesions outside the target volume.

  4. Functional Assessment of Cancer Therapy - Brain (FACT-Br)

    Time frame: Prior to treatment; 30 days post treatment; 8 -12 weeks, 22-28 weeks, 30-42 weeks, 45-60 weeks, 64-74 weeks, 80-84 weeks, 90-96 weeks,100-112 weeks, 120-124 weeks, 130-140 weeks, 145-155 weeks, and 160-170 weeks post treatment

    Functional Assessment of Cancer Therapy - Brain (FACT-Br) is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. Scores range from 0-108, with higher scores indicating better Quality of Life.

Sponsors and collaborators

Lead sponsor

Steven Burton

Other

Registry information

Official study title

PHASE I STUDY OF FRACTIONATED STEREOTACTIC RADIOSURGERY FOR LARGE BRAIN METASTASES

Important dates

Study start
2013
Primary completion
2017
Study completion
2023
First posted
Feb 4, 2014
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.