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Completed

NCT Number: NCT01252797

Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)

This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain and spinal cord.

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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

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hazelrig-Salter Radiation Oncology Center/University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

This study will attempt to determine the maximum tolerated dose of pre-operative stereotactic radiosurgery (SRS) in the treatment of brain metastases. Patients will be placed in one of two dose groups based on index tumor size, and dose will be adjusted according to presence or absence of dose limiting toxicity (DLT).

Group A: Index Tumor > 2 cm and up to 4 cm in maximum diameter Group B: Index Tumor > 4 cm and up to 6 cm in maximum diameter

Dose escalation or de-escalation will be conducted via a modified 3+3 method at the following levels. Group A will start at dose level II. Group B will start at dose level I.

Dose Level I: 12 Gy Dose Level II: 15 Gy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All subjects must have history of histologically confirmed malignancy. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician.
  • Newly diagnosed brain metastases (four or fewer by post-contrast MRI obtained within six weeks of study entry)
  • At least one brain metastasis (index tumor) must be within 2-6 cm in maximum diameter and deemed appropriate for surgical resection by the treating neurosurgeon.
  • Karnofsky performance status (KPS) of greater than or equal to 60
  • Age greater than 19
  • Life expectancy greater than 12 weeks
  • Subjects given written informed consent

Exclusion criteria

  • Patients with small cell lung cancer and lymphoma are ineligible.
  • More than four metastases by baseline post-contrast MRI
  • Prior whole brain radiation therapy
  • Insufficient recovery from all active toxicities of prior therapies
  • Subjects who are deemed to be poor surgical risks by the treating neurosurgeon because of medical comorbidities
  • Pregnant or nursing women
  • Women of childbearing potential who are not using an effective method of contraception are excluded. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to administration of SRS.

Treatment and study plan

Stereotactic Radiosurgery (15 Gy)

Radiation

Group A will start at dose level II: 15 Gy

Group B will start at dose level I: 12 Gy

Stereotactic Radiosurgery (12 Gy)

Radiation

Group B will start at Dose Level I: 12 Gy

Primary outcomes

  1. maximum tolerated dose (MTD) of preoperative stereotactic radiosurgery (SRS) for brain metastasis

    Time frame: one year

    The maximum tolerated dose (MTD) is defined as the highest dose of stereotactic radiosurgery delivered pre-operative at which no more than 2 out of 6 patients experience a dose limiting toxicity (DLT).

Secondary outcomes

  1. Acute Toxicity with preoperative stereotactic radiosurgery (SRS)

    Time frame: 6 months

    Any possible, probable, or definite treatment-related AE or SAE (assessed by CTCAE 4.0) occurring within six months or less from the date of stereotactic radiosurgery was received.

  2. Late Toxicity with preoperative stereotactic radiosurgery (SRS)

    Time frame: 1 year

    Any possible, probable, or definite treatment-related AE or SAE (assessed by CTCAE 4.0) occurring more than six months from the date of stereotactic radiosurgery was received.

  3. Rates of Local Control

    Time frame: 2 years

    This will be assessed by MRI Imaging obtained post-operatively at follow-up visits.

  4. Rates of Leptomeningeal Dissemination

    Time frame: 2 years

    Leptomeningeal Dissemination (LMD) defined as diffuse carcinomatosis and/or distant focal pachymeningeal (dural) tumor and assessed by MRI Imaging for the study period.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

RAD 1002: Phase I Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases

Acronym: RAD 1002

Important dates

Study start
2010
Primary completion
2016
Study completion
2018
First posted
Dec 3, 2010
Registry last updated
May 14, 2018

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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