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Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases

Primary Purpose

Brain Metastasis, Bladder Cancer, Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Radiosurgery
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastasis focused on measuring Cancer, Brain Metastasis, Radiosurgery, Bladder cancer, Breast cancer, Cervical cancer, Colon cancer, HEENT cancer, Lung cancer, Melanoma, Pancreatic cancer, Prostate cancer, Rectal cancer, Sarcoma, Testicular cancer, Radiation

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed malignancy with the presence of one or two intraparenchymal brain metastases (newly diagnosed patients may be registered based on radiologic confirmation if pathology is unavailable)
  • Age ≥ 18 years
  • Karnofsky performance status ≥ 70
  • Neurologic Function Status 0-2
  • Patients may have extracranial sites of metastatic disease
  • Adequate bone marrow reserve (hemoglobin ≥ 8 grams, absolute neutrophil count ≥ 1000/mm3, platelets ≥ 50,000/mm3)
  • Patient must sign a study specific informed consent form.

Exclusion Criteria:

  • Major medical illness including poor cardiac, pulmonary or renal status which would result in patient being a high risk candidate for neurosurgical procedure
  • Inability to obtain histologic proof of malignancy
  • Patients with leptomeningeal metastases documented by MRI or CSF evaluation Patients with metastases within 10 mm of the optic apparatus so that some portion of the optic nerve or chiasm would be included in the high dose SRS boost field
  • Patients with metastases in the brainstem, midbrain, pons, or medulla
  • Patients with small cell lung cancer, germ-cell tumors, lymphoma, leukemia and multiple myeloma are not eligible
  • Younger than 18 years of age
  • Karnofsky performance status of ≤ 60
  • Prior history of whole brain radiation therapy
  • Concomitant use of chemotherapy or targeted biological therapy (within a week of the SRS treatment)
  • ≥ 3 metastases in the brain
  • Allergy to both CT and MR contrast dyes
  • Platelet count of < 100,000 or coagulation disorders that cannot be corrected or would render the surgery a high-risk procedure

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Local Control
following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI. No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease.

Secondary Outcome Measures

Full Information

First Posted
December 26, 2007
Last Updated
January 22, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00587964
Brief Title
Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
Official Title
Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
For patients who have one or two metastases in the brain, the tumor(s) can often be removed with surgery to relieve symptoms from the tumor(s) and to improve survival. However, about half of all patients who have the tumor(s) removed with surgery will develop regrowth (recurrence) of the tumor. To prevent this regrowth of tumor, some patients receive radiation to the entire brain (whole brain radiation) after surgery. This involves daily treatment for about two to three weeks, and may cause long-term neurological problems, such as memory loss. Stereotactic radiosurgery (SRS) is sometimes used instead of surgery to treat brain metastasis. This involves the use of a special head frame and sophisticated computer programs that enable us to deliver a high dose of radiation to a small focused area of the brain in only one treatment. Research has shown that the results of treatment with SRS are as good as surgical removal of the tumor. SRS and surgical resection are considered the standard options for the treatment of brain metastases. This Phase II clinical trial is studying the combination of these two techniques. The purpose of this study is to evaluate the use of SRS following surgical removal of brain metastases. The outcomes we will be looking at are tumor regrowth after treatment and side effects of treatment.
Detailed Description
This is a phase II trial in patients with 1-2 brain metastases treated with surgical resection followed by stereotactic radiosurgery boost. Following surgical resection, patients would receive a stereotactic radiosurgery boost to the surgical bed, 2-8 weeks after surgery. A dose of 15 to 22 Gy would be delivered in a single fraction. Patient would be subsequently followed clinically and radiologically to watch for local control as well as toxicity. If a recurrence or new metastasis(es) is detected, further treatment may be given, consisting of chemotherapy, surgery, whole brain radiation therapy or stereotactic radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastasis, Bladder Cancer, Breast Cancer, Cervical Cancer, Colon Cancer, HEENT Cancer, Lung Cancer, Melanoma, Pancreatic Cancer, Prostate Cancer, Rectal Cancer, Sarcoma, Testicular Cancer
Keywords
Cancer, Brain Metastasis, Radiosurgery, Bladder cancer, Breast cancer, Cervical cancer, Colon cancer, HEENT cancer, Lung cancer, Melanoma, Pancreatic cancer, Prostate cancer, Rectal cancer, Sarcoma, Testicular cancer, Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiosurgery
Other Intervention Name(s)
SRS
Intervention Description
All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases. The patient will initially receive premedication with 0.5- 1mg of Ativan orally prior to SRS procedure. Subsequently, the patient will have the stereotactic head ring placement under local anesthesia. A peripheral IV will be placed for administration of the intravenous contrast. Thin-section CT images will be obtained with intravenous contrast with head ring in place for the purpose of treatment planning. A fusion program will be used to combine the recently obtained MRI images along with the CT scans. The target volume as well as the critical structures will be contoured. SRS would be delivered using either the Brain Lab or Radionics Radiosurgery planning and delivery system. Patients would receive a single treatment ranging from 15-22 GY.
Primary Outcome Measure Information:
Title
Local Control
Description
following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI. No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed malignancy with the presence of one or two intraparenchymal brain metastases (newly diagnosed patients may be registered based on radiologic confirmation if pathology is unavailable) Age ≥ 18 years Karnofsky performance status ≥ 70 Neurologic Function Status 0-2 Patients may have extracranial sites of metastatic disease Adequate bone marrow reserve (hemoglobin ≥ 8 grams, absolute neutrophil count ≥ 1000/mm3, platelets ≥ 50,000/mm3) Patient must sign a study specific informed consent form. Exclusion Criteria: Major medical illness including poor cardiac, pulmonary or renal status which would result in patient being a high risk candidate for neurosurgical procedure Inability to obtain histologic proof of malignancy Patients with leptomeningeal metastases documented by MRI or CSF evaluation Patients with metastases within 10 mm of the optic apparatus so that some portion of the optic nerve or chiasm would be included in the high dose SRS boost field Patients with metastases in the brainstem, midbrain, pons, or medulla Patients with small cell lung cancer, germ-cell tumors, lymphoma, leukemia and multiple myeloma are not eligible Younger than 18 years of age Karnofsky performance status of ≤ 60 Prior history of whole brain radiation therapy Concomitant use of chemotherapy or targeted biological therapy (within a week of the SRS treatment) ≥ 3 metastases in the brain Allergy to both CT and MR contrast dyes Platelet count of < 100,000 or coagulation disorders that cannot be corrected or would render the surgery a high-risk procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Beal, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering web site

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Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases

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