Evaluation of Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Cancer

Stanford University48 enrolled

Overview

This study has two primary objectives. The first objective is to determine the maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors. Once the MTD is established, the second objective is to determine the efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

Stereotactic radiosurgeryPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria:1.Lung tumor \>= 5.0 cm. 2.Age \> 18 years, 3.Histologic confirmation of malignancy (primary lung or metastatic tumor) 4.Deemed unresectable either by radiographic criteria (such as direct invasion of the mediastinum, heart, great vessels, or trachea), by virtue of excessive risk to patient, patient refusal to undergo surgery, or prior operative findings. 5.Performance status of 0-2 by Eastern Clinical Oncology Group criteria Exclusion Criteria:1. No chemotherapy within 2 weeks of radiation treatment. 2\. Refusal to sign informed consent. 3\. Refusal to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential.

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

Maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors

Efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses

Data from ClinicalTrials.gov

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