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CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Lung Cancer

A Prospective Evaluation of Outcomes of Radiosurgical Treatment of Early Stage Non-Small Cell Lung Cancer (NSCLC)

NCT00643318•Accuray Incorporated

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the short and long-term outcomes after CyberKnife stereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients who are medically inoperable.

Detailed Description

The objectives of this clinical evaluation are to assess the outcomes of patients who undergo stereotactic radiosurgery (SRS) to treat primary early stage non-small cell lung cancer (NSCLC) in patients (comprising of two cohorts, peripheral and central) who are not candidates for surgical resection because of high operative risks. In particular, the effect of CyberKnife SRS on clinical response rate, local control, progression-free survival, overall survival, dyspnea and QOL (for U.S. sites), and radiological findings over two years after treatment will be evaluated.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient must be over the age of 18 years
•2. Pulmonary nodule with maximum diameter ≤ 5 cm
•3. Histological confirmation of primary NSCLC
•4. The following stage of NSCLC patients are eligible:
•* Stage I: T1 N0 M0 or T2 N0 M0 (Tumor size ≤ 5 cm)
•* Stage II: T3 N0 M0 (Chest wall invasion only, Tumor size ≤ 5 cm)
•5. ECOG/Zubrod status of 0, 1 or 2
•6. Thoracic surgery consultation should be obtained from a Board Certified Thoracic surgeon who in collaboration with a radiation oncologist should determine that the patient is not a surgical candidate.
•7. In order to be considered medically inoperable, the patient must meet at least one major criteria or a minimum of 2 minor criteria as described below:
•MAJOR CRITERIA:
+27 more criteria

Exclusion Criteria

•1. Excluding the primary cancer targeted for this treatment, the patient has a prior history of cancer (within the last 5 years) or concurrent cancer other than basal cell or squamous skin cancer.
•2. Visible endobronchial lesion seen in the trachea, carina, major bronchus, lobar or segmental bronchus on bronchoscopy or microscopic disease detected in the trachea, carina, major bronchus, lobar or segmental bronchus.
•3. The patient's weight exceeds the tolerances of the institution's imaging and CyberKnife platform/couch.
•4. The patient has received thoracic radiation therapy in the same field as the planned treatment area in the past.
•5. The patient has completed chemotherapy within less than 30 days of treatment.
•6. T2: Tumor size \> 5 cm, T3 tumors (except T3 by virtue of chest wall invasion and ≤ 5 cm), T4 tumors. Presence of N1, N2 or N3 disease per previously described criteria would be excluded.
•7. Pancoast tumors would be excluded.
•8. Current distant metastatic disease (M1) (preferably biopsy proven).
•9. The patient is a female with child-bearing potential who refuses to take a pregnancy test prior to treatment.
•10. The patient is pregnant or a female who is nursing an infant.
+2 more criteria

Locations (23)

St Joseph's Hospital/Barrow Neurological Institute

Phoenix, Arizona, United States

Community Regional Medical Center

Fresno, California, United States

Stanford University

Palo Alto, California, United States

Penrose Cancer Center

Colorado Springs, Colorado, United States

Denver CyberKnife

Lone Tree, Colorado, United States

North Florida Radiation Oncology

Gainesville, Florida, United States

Naples Community Hospital

Naples, Florida, United States

Northwest Community Hospital

Arlington Heights, Illinois, United States

Advocate Christ Med Center

Oak Lawn, Illinois, United States

Parkview Cancer Center

Fort Wayne, Indiana, United States

Key Dates

Start Date

April 1, 2006

Primary Completion Date

December 1, 2021

Completion Date

December 1, 2021

Last Updated

March 5, 2021

Enrollment

ACTUAL participants

Conditions

Non-small Cell Lung Cancer

Interventions

CyberKnife Stereotactic Radiosurgery

RADIATION

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)