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

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ClinicalTrials.gov Identifier: NCT00587964
Recruitment Status : Completed
First Posted : January 8, 2008
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE December 26, 2007
First Posted Date  ICMJE January 8, 2008
Results First Submitted Date  ICMJE December 14, 2015
Results First Posted Date  ICMJE February 22, 2016
Last Update Posted Date February 22, 2016
Study Start Date  ICMJE June 2004
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2016)
Local Control [ Time Frame: 1 year ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2008)
To determine the 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 [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
Official Title  ICMJE Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Metastasis
  • Bladder Cancer
  • Breast Cancer
  • Cervical Cancer
  • Colon Cancer
  • HEENT Cancer
  • Lung Cancer
  • Melanoma
  • Pancreatic Cancer
  • Prostate Cancer
  • Rectal Cancer
  • Sarcoma
  • Testicular Cancer
Intervention  ICMJE Radiation: Stereotactic Radiosurgery

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.

Other Name: SRS
Study Arms  ICMJE Experimental: Treatment
Intervention: Radiation: Stereotactic Radiosurgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2016)
51
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2008)
50
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00587964
Other Study ID Numbers  ICMJE 04-061
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathryn Beal, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP