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

NCT ID: NCT00238602

Last Updated: 2012-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Stereotactic radiosurgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Billy W. Loo Jr. M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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78730

Identifier Type: -

Identifier Source: secondary_id

LUN0008

Identifier Type: -

Identifier Source: secondary_id

NCT00238602

Identifier Type: -

Identifier Source: secondary_id

LUN0008

Identifier Type: -

Identifier Source: org_study_id