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Active, Not Recruiting

NCT Number: NCT03726359

Phase I Study of Fractionated Stereotactic Radiation Therapy

There is a lack of prospective trial data and consensus guidelines describing the use of Fractionated Stereotactic Radiation Therapy (FSRT) in the treatment of brain metastases. There has been no prospective dose escalation study performed to date to determine the maximum tolerated dose (MTD) in patients treated with FSRT. Prescription doses in the series described above ranged from 18 Gy to 42 Gy, delivered in 3 to 12 fractions. The results of this study will be used to plan future Phase II/III studies to determine the efficacy of different dose fractionation schedules of FSRT. The investigator team thus proposes a Phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathologically proven diagnosis of a non-hematological malignancy other than small cell lung cancer within 5 years of registration
  • Intact (unresected) brain metastases measuring ≥3 cm and ≤ 6 cm in largest dimension on gadolinium contrast enhanced MRI obtained within 30 days prior to registration OR Surgically resected brain metastasis for which postoperative stereotactic radiotherapy is indicated, with expected target measuring ≥3 cm and ≤6 cm in largest dimension
  • Prior Whole Brain Radiation Therapy (WBRT) is allowed
  • Age ≥ 18 years
  • Women of childbearing potential and male participants must practice adequate contraception
  • History/Physical examination within 30 days prior to registration
  • Life expectancy >3 months
  • Patients are allowed to enroll if previously treated to other lesions with Stereotactic Radiosurgery (SRS)
  • Patients with multiple lesions are allowed, as long there is one dominant lesion that will be treated with FSRT. Other lesions may be treated concurrently with SRS or FSRT at the discretion of the treating physician but will not contribute to the study endpoints

Exclusion criteria

  • Patients with definitive leptomeningeal metastases, based on cerebrospinal fluid (CSF) examination
  • Plan for chemotherapy or targeted agents during treatment. Hormonal therapy, immunotherapy targeting PD-1/PD-L1 axis, and bone supportive therapy may be continued during treatment
  • Contraindication to enhanced MRI imaging such as implanted metal devices. However, patients with implanted devices which are MRI compatible are allowed
  • Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy
  • Uncontrolled intercurrent illness such as congestive heart failure, unstable angina, cardiac arrhythmia, and uncontrolled seizure activity
  • Previous treatment of the target lesion with radiotherapy

Treatment and study plan

Fractionated Stereotactic Radiation Therapy (FSRT)

Radiation

Initial starting dose will be 7 Gy x5= 35 Gy delivered to the planning target volume (PTV). Radiotherapy will be delivered every other day so that the Stereotactic Body Radiation Therapy (SBRT) schedule is completed within 1.5-2 weeks.

Primary outcomes

  1. Maximum Tolerated Dose (MTD)

    Time frame: Within 1 year of initiation of treatment

    Determine the maximum tolerated dose (MTD) associated with a 20% probability of dose limiting toxicity (DLT). DLT is defined as grade 3 or higher toxicities (per CTCAE version 4.03; MedDRA version 12.0) that occur within 1 year of treatment start and are either possibly, probably, or definitively related to radiotherapy (RT), and related to the specific symptoms.

Secondary outcomes

  1. Response to Treatment

    Time frame: Up to 1 year following initiation of treatment

    Response to treatment will be assessed based on the percentage of patients who achieve either a complete response (CR), partial response (PR), or stable disease (SD), or progression (P) in response to FSRT treatment. Best response will be summarized. Response criteria will be assessed as follows:

    Complete Response (CR): Defined as follow up imaging which shows that complete radiographic disappearance of brain metastasis Partial Response (PR): Decrease of >50% in the size of each lesion radiographically, using perpendicular diameters Stable Disease (SD): 0 to 50% reduction in size of each lesion radiographically, using perpendicular diameters Progression (P): Defined as > 25% increase in the size of each lesion or a new, non-contiguous lesion developed outside of the radiosurgical volume

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Registry information

Official study title

Phase I TITE-CREM Dose Escalation Study of Fractionated Stereotactic Radiation Therapy (FSRT) in Unresected Brain Metastases

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Oct 31, 2018
Registry last updated
Jul 8, 2026

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.

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