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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiosurgery | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Beal, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering web site | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment - Stereotactic Radiosurgery | Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment - Stereotactic Radiosurgery | Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | 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. | Posted | Number | participants | 1 year |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment - Stereotactic Radiosurgery | Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases. | 16 | 51 | 0 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTC-2.0 | Systematic Assessment |
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| Ischemia cerebrovascular | Nervous system disorders | CTC-2.0 | Systematic Assessment |
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| Confusion | Nervous system disorders | CTC-2.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| General symptom | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Radiation oesophagitis | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Headache | General disorders | CTC-2.0 | Systematic Assessment |
| |
| Hypomagnesemia | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Neurological disorder | Nervous system disorders | CTC-2.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTC-2.0 | Systematic Assessment |
| |
| Platelets count decrease | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTC-2.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | CTC-2.0 | Systematic Assessment |
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| Thrombosis | Cardiac disorders | CTC-2.0 | Systematic Assessment |
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| Vision-blurred vision | Eye disorders | CTC-2.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathryn Beal | Memorial Sloan Kettering Cancer Center | 212-639-5159 | bealk@mskcc.org |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D001943 | Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D003110 | Colonic Neoplasms |
| D008175 | Lung Neoplasms |
| D008545 | Melanoma |
| D010190 | Pancreatic Neoplasms |
| D011471 | Prostatic Neoplasms |
| D012004 | Rectal Neoplasms |
| D012509 | Sarcoma |
| D013736 | Testicular Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D012002 | Rectal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Title | Measurements |
|---|---|
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| Relapse/Recurrence |
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