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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Refusal to sign informed consent.

Refusal to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential.

Treatment and study plan

Stereotactic radiosurgery

Procedure

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Evaluation of the Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Tumors - A Phase I/II Study

Important dates

Study start: 2000
Primary completion: 2007
Study completion: 2012
First posted: Oct 13, 2005
Registry last updated: Jul 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed