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

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ClinicalTrials.gov Identifier: NCT01252797
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
John Fiveash, MD, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: Stereotactic Radiosurgery (15 Gy) Radiation: Stereotactic Radiosurgery (12 Gy) Phase 1

Detailed Description:

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: RAD 1002: Phase I Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases
Study Start Date : October 2010
Actual Primary Completion Date : November 2016
Actual Study Completion Date : April 2018

Arm Intervention/treatment
Active Comparator: Stereotactic Radiosurgery (15 Gy)
Group A: If the tumor which will be surgically removed is at least 2 cm and up to 4 cm in maximum diameter, then this group will receive Dose Level II (15 Gy) of radiation: stereotactic radiosurgery (SRS) followed by surgery to remove the tumor.
Radiation: Stereotactic Radiosurgery (15 Gy)

Group A will start at dose level II: 15 Gy

Group B will start at dose level I: 12 Gy


Experimental: Stereotactic Radiosurgery (12Gy)
Group B: If the tumor which will be surgically removed is larger than 4 cm and up to 6 cm in diameter, then this group will receive Dose Level I (12 Gy) of radiation: stereotactic radiosurgery (SRS) followed by surgery to remove the tumor.
Radiation: Stereotactic Radiosurgery (12 Gy)
Group B will start at Dose Level I: 12 Gy




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252797


Locations
United States, Alabama
Hazelrig-Salter Radiation Oncology Center/University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: John B. Fiveash, MD Hazelrig-Salter Radiation Oncology Center (HSROC)/ University of Alabama at Birmingham (UAB)

Responsible Party: John Fiveash, MD, Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01252797     History of Changes
Other Study ID Numbers: F100528006
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by John Fiveash, MD, University of Alabama at Birmingham:
brain metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases