search
Back to results

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

Primary Purpose

Brain Metastases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Radiosurgery (15 Gy)
Stereotactic Radiosurgery (12 Gy)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brain Metastases focused on measuring brain metastases

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stereotactic Radiosurgery (15 Gy)

Stereotactic Radiosurgery (12Gy)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Acute Toxicity with preoperative stereotactic radiosurgery (SRS)
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.
Late Toxicity with preoperative stereotactic radiosurgery (SRS)
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.
Rates of Local Control
This will be assessed by MRI Imaging obtained post-operatively at follow-up visits.
Rates of Leptomeningeal Dissemination
Leptomeningeal Dissemination (LMD) defined as diffuse carcinomatosis and/or distant focal pachymeningeal (dural) tumor and assessed by MRI Imaging for the study period.

Full Information

First Posted
November 22, 2010
Last Updated
May 10, 2018
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT01252797
Brief Title
Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)
Acronym
RAD 1002
Official Title
RAD 1002: Phase I Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
brain metastases

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Radiosurgery (15 Gy)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stereotactic Radiosurgery (12Gy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiosurgery (15 Gy)
Intervention Description
Group A will start at dose level II: 15 Gy Group B will start at dose level I: 12 Gy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiosurgery (12 Gy)
Intervention Description
Group B will start at Dose Level I: 12 Gy
Primary Outcome Measure Information:
Title
maximum tolerated dose (MTD) of preoperative stereotactic radiosurgery (SRS) for brain metastasis
Description
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).
Time Frame
one year
Secondary Outcome Measure Information:
Title
Acute Toxicity with preoperative stereotactic radiosurgery (SRS)
Description
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.
Time Frame
6 months
Title
Late Toxicity with preoperative stereotactic radiosurgery (SRS)
Description
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.
Time Frame
1 year
Title
Rates of Local Control
Description
This will be assessed by MRI Imaging obtained post-operatively at follow-up visits.
Time Frame
2 years
Title
Rates of Leptomeningeal Dissemination
Description
Leptomeningeal Dissemination (LMD) defined as diffuse carcinomatosis and/or distant focal pachymeningeal (dural) tumor and assessed by MRI Imaging for the study period.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John B. Fiveash, MD
Organizational Affiliation
Hazelrig-Salter Radiation Oncology Center (HSROC)/ University of Alabama at Birmingham (UAB)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hazelrig-Salter Radiation Oncology Center/University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs