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Non-small Cell Lung CancerPhase 2NCT00643318

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

A Phase 2 study testing CyberKnife Stereotactic Radiosurgery in people with Non-small Cell Lung Cancer, run by Accuray Incorporated at 23 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
CyberKnife Stereotactic Radiosurgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
23 sitesin 2 countries
Study dates
Apr 2006to Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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%)
  • Unstable coronary syndromes (unstable angina or severe angina Canadian class III or IV).
  • Severe valvular disease (critical valvular stenosis),
  • Recent myocardial infarction (< 1 month),
  • Significant arrhythmia defined by one of the following: High-grade AV block, Symptomatic ventricular arrhythmias in the presence of underlying heart disease, Supraventricular arrhythmias with uncontrolled ventricular rate
  • MINOR CRITERIA:
  • Age > 75
  • Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg)
  • Oxygen requirement (using the Medicare criteria for home oxygen requirements [i.e., room air oxygen saturation of 88% or less])
  • Resting or exercise arterial pO2 ≤ 55 mm Hg OR SpO2 ≤ 88%.
  • pCO2 > 45 mm Hg
  • Congestive heart failure (any three of the following must be documented: dyspnea, peripheral edema, chest x-ray with interstitial edema or cardiomegaly, rales, or congestion)
  • Moderately depressed left ventricular function (defined as an ejection fraction of 21-40% or less)
  • Severe cerebral (with CVA or recent TIA) or severe peripheral vascular disease
  • Diabetes Mellitus with severe organ damage such as ESRD, Blindness, Vascular disease.
  • Severe end organ damage from other causes resulting in ESRD, cirrhosis of the liver or vascular disease
  • FEV1 51%-60% or predicted postoperative FEV1 41-50%
  • DLCO 51-60% or predicted postoperative DLCO 41-50%
  • Modified Medical Research Council Dyspnea Scale ≥ grade 3
  • Females of child-bearing age must be using a reliable form of birth control.
  • The patient must have a PET-CT scan within 8 weeks of registration.
  • The patient must provide a signed and dated written informed consent PRIOR to registration and prior to undergoing any study-related procedures.
  • The patient must provide written authorization to allow the use and disclosure of their protected health information.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

United States21 sites

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Penrose Cancer Center

    Colorado Springs, Colorado, 80907

  • Baylor Research Institute

    Dallas, Texas, 75204

  • Parkview Cancer Center

    Fort Wayne, Indiana, 46845

  • Community Regional Medical Center

    Fresno, California, 93721

  • North Florida Radiation Oncology

    Gainesville, Florida, 32605

  • St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Denver CyberKnife

    Lone Tree, Colorado, 80124

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • St. Catherine's Hospital

    Munster, Indiana, 46321

  • Naples Community Hospital

    Naples, Florida, 34102

  • Advocate Christ Med Center

    Oak Lawn, Illinois, 60453

  • St. Anthony's Hospital

    Oklahoma City, Oklahoma, 73101

  • Stanford University

    Palo Alto, California, 94305

  • St Joseph's Hospital/Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • St. Mary's Regional Medical Center

    Reno, Nevada, 89503

  • St. Louis University Hospital

    St Louis, Missouri, 63110

  • Multicare Health System

    Tacoma, Washington, 98405

Other trials in United States

China2 sites

  • Ruikang Hospital

    Nanning, Guangxi, 530011

  • Tianjin Medical University Cancer Institution and Hospital

    Tianjin, 300060

Other trials in China

About this study

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

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.

Read the 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.

Being tested
CyberKnife Stereotactic Radiosurgery
Keywords
lung cancer, lung tumor, non-small cell lung cancer, NSCLC, CyberKnife, radiosurgery, lung surgery
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyberKnife Stereotactic RadiosurgeryRadiation

    Also called CyberKnife, Stereotactic Radiosurgery, Radiosurgery, Radiation Therapy

    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)

Study groups in NCT00643318
Study groupRoleWhat they receive
CyberKnife Stereotactic RadiosurgeryExperimentalNot described
Receives: Radiation: CyberKnife Stereotactic Radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 5 years

Secondary outcomes (1)

  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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2008 (estimated)
  2. Study startApr 2006
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00643318
Sponsor's protocol ID
ACCL001.0
Status last verified
Aug 2019
First submitted
20 Mar 2008
Last updated
5 Mar 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CyberKnife Stereotactic Radiosurgery in people with Non-small Cell Lung Cancer, run by Accuray Incorporated at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local progression-free survival, local disease progression, clinical response rate, regional recurrence-free survival, distant recurrence-free survival. (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00643318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.

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