A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection

NCT02005614 | Terminated DMC

• 1 other identifier: 1306012291
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect prospective data for use as a comparator for future subsequent studies attempting to increase the efficacy or reduce the toxicity of gamma knife radiosurgery.

Conditions

Melanoma; Renal Cell Carcinoma; Sarcoma; Breast Cancer; Lung Cancer; Colorectal Cancer; Gastrointestinal Cancers; Brain Metastases

Keywords

Rational dose selection; gamma knife radiosurgery

Outcome Measures

Primary Outcomes (1)

• Rate of Local Control Over time (RECIST Criteria)

  Response or progression of the radiated lesion will be measured by change in the largest unidimensional measurement. Additionally, response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Local control is defined as a lack of progressive disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria of a 20% increase in the longest diameter for a target lesion. If the lesion grows beyond 20% of the longest diameter of the pre-treatment, but subsequently regresses without further lesion-targeted radiotherapy, it will be assumed that the lesion was treatment related radiation necrosis in analysis

  Up to 2 years

Study Arms (1)

Gamma Knife Radiosurgery

EXPERIMENTAL

"Rational dose selection" is a concept wherein doses used for stereotactic radiosurgery is selected based on tumor volume, prior irradiation with whole brain radiotherapy, and the relative radioresistance of the tumor (radioresistant = melanoma, renal cell carcinoma, sarcoma; radiosensitive = breast cancer, lung cancer, colorectal cancer, gastrointestinal cancers). Dose may be altered for lesions in the brainstem, adjacent to the optic nerve, optic chiasm, or motor cortex, or other clinical scenarios as defined by the treating physician. Reason for dose alteration will be recorded at the time of treatment. For patients with 10+ brain metastases with multimorbidity or difficulty in tolerating a supine position, doses may be modified by the treating physicians for patient comfort.

Procedure: Gamma Knife Radiosurgery

Interventions

Gamma Knife Radiosurgery PROCEDURE

Treatment will be administered on an outpatient basis. No other treatment, investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's brain metastases. Gamma knife radiosurgery is a one day out-patient procedure. Time from initiation of treatment (premedication and placement of a stereotactic frame) until end of treatment (completion of radiation delivery and removal of stereotactic frame) ranges from 3 to 16 hours.

Gamma Knife Radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed malignancy (not leukemia or lymphoma). There must be metastatic brain disease apparent on magnetic resonance imaging which offers a medical indication for brain radiation. - Age \> 18
• Karnofsky Performance Status \> 70
• MRI performed within 4 weeks of trial enrollment
• Medical oncologist or consenting physician verifies that chemotherapy options exist after treatment with intracranial therapy, and that chemotherapy is planned to initiate after completion of radiation. Or, survival as estimated by the medical oncologist or enrolling physician is \> 3 months.

You may not qualify if:

• Extremely radiosensitive tumor (lymphoma, leukemia)
• Radiosensitivity syndrome (scleroderma, dermatomyositis, other genetic syndrome that predisposes to adverse radiotherapy complications)
• Evidence of leptomeningeal dissemination
• Resection of brain metastases, otherwise untreated with radiation for those brain lesions (presenting for postoperative consolidative radiotherapy)
• Presence of a medical device (pacemaker, stent) or allergy that precludes contrast enhanced MRI
• Patient is unable to tolerate placement of a stereotactic headframe
• Pregnancy

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Renal Cell; Sarcoma; Breast Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Gastrointestinal Neoplasms; Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms, Connective and Soft Tissue; Breast Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• James B Yu, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: November 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 1, 2019

Record last verified: 2019-06

Locations

US (1)