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

NCT00643318 | Unknown Phase 2

• 1 other identifier: ACCL001.0
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 23

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

lung cancer; lung tumor; non-small cell lung cancer; NSCLC; CyberKnife; radiosurgery; lung surgery

Outcome Measures

Primary Outcomes (1)

• Local progression-free survival, local disease progression, clinical response rate, regional recurrence-free survival, distant recurrence-free survival.

  5 years

Secondary Outcomes (1)

• To characterize and compare quality of life before and after stereotactic radiosurgery treatment. To assess procedure-related outcomes after stereotactic radiosurgery of lung tumors.

  5 years

Study Arms (1)

CyberKnife Stereotactic Radiosurgery

EXPERIMENTAL

Radiation: CyberKnife Stereotactic Radiosurgery

Interventions

CyberKnife Stereotactic Radiosurgery RADIATION

Central tumors defined as \< 2 cm from carina and \< 2 cm from right and left mainstem bronchus and/or \< 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus, and the right and left lower lobe bronchus. For central tumors, 4 fractions of 12 Gy will be delivered (12 Gy x 4 fractions = 48 Gy) Peripheral tumors are defined as being \> 2 cms from the carina and \> 2 cms from the right and left mainstem bronchus and/or \> 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus and the right and left lower lobe bronchus. For peripheral tumors, 3 fractions of 20 Gy will be delivered (20 Gy x 3 fractions = 60 Gy)

Also known as: CyberKnife, Stereotactic Radiosurgery, Radiosurgery, Radiation Therapy

CyberKnife Stereotactic Radiosurgery

Eligibility Criteria

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

You may qualify if:

• Patient must be over the age of 18 years
• Pulmonary nodule with maximum diameter ≤ 5 cm
• Histological confirmation of primary NSCLC
• 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)
• ECOG/Zubrod status of 0, 1 or 2
• 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.
• 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:
• FEV1 \< 50% or predicted postoperative FEV1 \< 40%
• DLCO \< 50% or predicted postoperative DLCO \< 40%
• Exercise induced maximal exercise oxygen consumption M VO2 \< 15 mL/kg/min
• High-risk cardiac disease: Any one of the following:
• Poor left ventricular function (defined as an ejection fraction of \<=20%)

You may not qualify if:

• 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.
• 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.
• The patient's weight exceeds the tolerances of the institution's imaging and CyberKnife platform/couch.
• The patient has received thoracic radiation therapy in the same field as the planned treatment area in the past.
• The patient has completed chemotherapy within less than 30 days of treatment.
• 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.
• Pancoast tumors would be excluded.
• Current distant metastatic disease (M1) (preferably biopsy proven).
• The patient is a female with child-bearing potential who refuses to take a pregnancy test prior to treatment.
• The patient is pregnant or a female who is nursing an infant.
• The patient is planning on undergoing systemic therapy within 2 weeks after the last fraction of radiation
• The patient has an active systemic or pulmonary infection.

Sponsors & Collaborators

• Accuray Incorporated: lead
• University of Pittsburgh: collaborator

Study Sites (23)

St Joseph's Hospital/Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Community Regional Medical Center

Fresno, California, 93721, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

Penrose Cancer Center

Colorado Springs, Colorado, 80907, United States

Location

Denver CyberKnife

Lone Tree, Colorado, 80124, United States

Location

North Florida Radiation Oncology

Gainesville, Florida, 32605, United States

Location

Naples Community Hospital

Naples, Florida, 34102, United States

Location

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Advocate Christ Med Center

Oak Lawn, Illinois, 60453, United States

Location

Parkview Cancer Center

Fort Wayne, Indiana, 46845, United States

Location

St. Catherine's Hospital

Munster, Indiana, 46321, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

St. Mary's Regional Medical Center

Reno, Nevada, 89503, United States

Location

St. Anthony's Hospital

Oklahoma City, Oklahoma, 73101, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor Research Institute

Dallas, Texas, 75204, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Multicare Health System

Tacoma, Washington, 98405, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Ruikang Hospital

Nanning, Guangxi, 530011, China

Location

Tianjin Medical University Cancer Institution and Hospital

Tianjin, 300060, China

Location

Related Links

• Accuray Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Radiosurgery; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• James Luketich, MD

  University of Pittsburgh Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 26, 2008
• Study Start: April 1, 2006
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 5, 2021

Record last verified: 2019-08

Locations

US (21); CN (2)