Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00587964

Purpose

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.

Condition	Intervention	Phase
Brain Metastasis Bladder Cancer Breast Cancer Cervical Cancer Colon Cancer HEENT Cancer Lung Cancer Melanoma Pancreatic Cancer Prostate Cancer Rectal Cancer Sarcoma Testicular Cancer	Radiation: Stereotactic Radiosurgery	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer breast cancer

MedlinePlus related topics: Bladder Cancer Breast Cancer Cancer Cervical Cancer Lung Cancer Melanoma Pancreatic Cancer Prostate Cancer Soft Tissue Sarcoma Testicular Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	June 2004
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment	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

Arms

Assigned Interventions

Experimental: Treatment

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587964

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Kathryn Beal, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering web site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Kathryn Beal, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00587964 History of Changes
Other Study ID Numbers:	04-061
Study First Received:	December 26, 2007
Last Updated:	March 20, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

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

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Breast Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Uterine Cervical Neoplasms
Lung Neoplasms
Melanoma
Neoplasm Metastasis
Neoplasms, Second Primary
Pancreatic Neoplasms
Prostatic Neoplasms
Testicular Neoplasms
Brain Neoplasms
Sarcoma
Urologic Neoplasms

Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 22, 2012