Lung CancerPhase 2NCT00551369
Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery
A Phase 2 study testing SBRT in people with Lung Cancer, run by Radiation Therapy Oncology Group at 19 sites in United States.
Trial summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue near the tumor. PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 19 sitesUnited States
- Study dates
- Dec 2007to 14 May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer, including any of the following primary tumor types:
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell carcinoma
- Large cell neuroendocrine tumor
- Non-small cell carcinoma not otherwise specified
- No pure type bronchoalveolar cell carcinoma
- Stage I or II disease based on 1 of the following combinations of primary tumor, regional nodes, metastasis (TNM) staging:
- T1, N0, M0
- T2 (≤ 5 cm), N0, M0
- T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)
- No T2 or T3 primary tumors > 5 cm or T3 primary tumors involving the central chest and structures of the mediastinum
- No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, or right and left lower lobe bronchi)
- Patients with hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on positron emission tomography (PET) scan will be considered N0
- Patients with > 1 cm hilar or mediastinal lymph nodes on CT scan OR abnormal PET scan (including suspicious but nondiagnostic uptake) will still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer
- No direct evidence of regional or distant metastases after appropriate staging studies
- Considered a reasonable candidate for surgical resection of the primary tumor, according to the following criteria:
- Primary tumor predicted to be technically resectable with a high likelihood of negative surgical margins (as determined by a qualified thoracic surgeon)
- Baseline forced expiratory volume (FEV)_1 > 35% predicted
- Postoperative predicted FEV_1 > 30% predicted
- Diffusion capacity > 35% predicted
- No hypoxemia (e.g., partial pressure of arterial oxygen (PaO2) of ≤ 60 mm Hg) and/or hypercapnia (e.g., partial pressure of arterial carbon dioxide (PaCO2) > 50 mm Hg) at baseline
- No severe pulmonary hypertension
- No severe cerebral, cardiac, or peripheral vascular disease
- No severe chronic heart disease
- Pleural effusion, if present, must be deemed too small to tap under CT scan guidance and must not be evident on chest x-ray
- Pleural effusion that appears on chest x-ray will be allowed only after thoracotomy or other invasive procedure
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Absolute neutrophil count ≥ 1,800/mm³
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No synchronous primary or other invasive malignancy within the past 3 years other than nonmelanoma skin cancer or in situ cancer
- No active systemic, pulmonary, or pericardial infection
- No weight loss > 5% for any reason within the past 3 months
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy for lung cancer
- Prior radiotherapy as part of treatment for head and neck cancer, breast cancer, or other non-lung cancer is allowed provided there will not be significant overlap with the stereotactic body radiotherapy fields
- No prior chemotherapy or surgical resection for this lung cancer
- No other concurrent local or regional antineoplastic therapy (including standard fractionated radiotherapy, non-approved systemic therapy, and surgery), except at disease progression
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
INOVA Alexandria Hospital
Alexandria, Virginia, 22304
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
St. Joseph Cancer Center
Bellingham, Washington, 98225
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, 94704
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, 95608
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, 49503
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, 94904
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, 40536-0093
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
NYU Cancer Institute at New York University Medical Center
New York, New York, 10016
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
University of California Davis Cancer Center
Sacramento, California, 95817
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Stony Brook University Cancer Center
Stony Brook, New York, 11794-9446
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Operable Stage I/II Non-Small Cell Lung Cancer
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue near the tumor.
PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using stereotactic body radiotherapy [SBRT] techniques) achieves acceptable primary tumor control (i.e., ≥ 90% at 2 years) in patients with resectable early-stage non-small cell lung cancer.
Secondary
- Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using SBRT techniques) achieves acceptable treatment-related toxicity.
- Estimate the disease-free survival and the overall survival rate at 2 years.
- Observe patterns of failure in the first 2 years.
- Assess the level of comorbidity burden on morbidity and efficacy.
- Determine if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2-year primary tumor control and predict for grade ≥ 2 treatment-related toxicities
OUTLINE: This is a multicenter study.
Patients receive 3 fractions of stereotactic body radiotherapy over 14 days. Patients with disease progression undergo surgical resection as salvage local therapy.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years and then annually thereafter.
- Conditions
- Lung Cancer
- Being tested
- SBRT
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, adenosquamous cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Also called Stereotactic body radiation therapy, Stereotactic ablative radiotherapy, SABR
SBRT delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Experimental | Stereotactic body radiation therapy (SBRT) Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Tumor Control at 2 Years
Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.
Measured: From start of treatment to 2 years.
Secondary outcomes (5)
Rate of Treatment-related Grade 3 or 4 Toxicity
The development of any treatment-related toxicity from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy
Measured: From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.
Other Grade 3-5 Adverse Events
The development of any treatment-related toxicity not from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy
Measured: From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.
Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years
PTF: the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure) within the first two years after start of SBRT. RF: the development of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum within the first two years after start of SBRT. MD: the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer within the first two years after start of SBRT. DFS: the state of being alive without development of progressive disease, with failure considered the earliest development of either progression or death. OS: the state of being alive, with failure is considered death due to any cause.
Measured: From start of treatment to 2 years.
Level of Comorbidity Burden on Morbidity and Efficacy
Measured: From start of treatment to end of follow-up.
Assessment of Predictive Value of Blood Markers for Primary Tumor Control at 2 Years and Treatment-related Adverse Events ≥ Grade 2
Assess if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2 year primary tumor control and predict for grade ≥ 2 treatment-related adverse events. Unfortunately, there were not enough specimens submitted to perform this analysis. The specimens that were collected remain in the NRG Oncology Biobank and are available to be combined with other specimens from other studies for an appropriately powered project.
Measured: From start of treatment to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startDec 2007
- Primary completionMay 2012
- Study completion14 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Robert D. Timmerman, MD, Principal investigator, Simmons Cancer CenterElizabeth M. Gore, MD, Study chair, Medical College of WisconsinHarvey I. Pass, MD, Study chair, NYU Langone HealthMartin J. Edelman, MD, Study chair, University of Maryland Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551369
- Sponsor's protocol ID
- RTOG-0618
- Other IDs
- CDR0000571744
- Status last verified
- Mar 2019
- First submitted
- 30 Oct 2007
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Timmerman RD, Paulus R, Pass HI, Gore EM, Edelman MJ, Galvin J, Straube WL, Nedzi LA, McGarry RC, Robinson CG, Schiff PB, Chang G, Loo BW Jr, Bradley JD, Choy H. Stereotactic Body Radiation Therapy for Operable Early-Stage Lung Cancer: Findings From the NRG Oncology RTOG 0618 Trial. JAMA Oncol. 2018 Sep 1;4(9):1263-1266. doi: 10.1001/jamaoncol.2018.1251.
PubMed 29852037
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Operable Stage I/II Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00551369
- Acronym / sponsor ID
- RTOG-0618
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, adenosquamous cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Study start
- Dec 2007 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 31 Oct 2007 (estimated)
- Results
- Posted 27 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue near the tumor.
PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using stereotactic body radiotherapy [SBRT] techniques) achieves acceptable primary tumor control (i.e., ≥ 90% at 2 years) in patients with resectable early-stage non-small cell lung cancer.
Secondary
- Determine whether treatment with radiotherapy involving a high biological dose with limited treatment volume (using SBRT techniques) achieves acceptable treatment-related toxicity.
- Estimate the disease-free survival and the overall survival rate at 2 years.
- Observe patterns of failure in the first 2 years.
- Assess the level of comorbidity burden on morbidity and efficacy.
- Determine if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2-year primary tumor control and predict for grade ≥ 2 treatment-related toxicities
OUTLINE: This is a multicenter study.
Patients receive 3 fractions of stereotactic body radiotherapy over 14 days. Patients with disease progression undergo surgical resection as salvage local therapy.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Experimental | Radiation: SBRTStereotactic body radiation therapy (SBRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTAlso: Stereotactic body radiation therapy, Stereotactic ablative radiotherapy, SABRSBRT delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy | Radiation | SBRT |
Primary outcome
Primary Tumor Control at 2 Years
Time frame: From start of treatment to 2 years.
Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.
5 secondary outcomes
Rate of Treatment-related Grade 3 or 4 Toxicity
Time frame: From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.
Other Grade 3-5 Adverse Events
Time frame: From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.
Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years
Time frame: From start of treatment to 2 years.
Level of Comorbidity Burden on Morbidity and Efficacy
Time frame: From start of treatment to end of follow-up.
Assessment of Predictive Value of Blood Markers for Primary Tumor Control at 2 Years and Treatment-related Adverse Events ≥ Grade 2
Time frame: From start of treatment to 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29852037Timmerman RD, Paulus R, Pass HI, Gore EM, Edelman MJ, Galvin J, Straube WL, Nedzi LA, McGarry RC, Robinson CG, Schiff PB, Chang G, Loo BW Jr, Bradley JD, Choy H. Stereotactic Body Radiation Therapy for Operable Early-Stage Lung Cancer: Findings From the NRG Oncology RTOG 0618 Trial. JAMA Oncol. 2018 Sep 1;4(9):1263-1266. doi: 10.1001/jamaoncol.2018.1251.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D. Timmerman, MD principal investigator
Simmons Cancer Center
Elizabeth M. Gore, MD study chair
Medical College of Wisconsin
Harvey I. Pass, MD study chair
NYU Langone Health
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT in people with Lung Cancer, run by Radiation Therapy Oncology Group at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Tumor Control at 2 Years (time frame: From start of treatment to 2 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 NCT00551369, which also lists 1 linked publication.
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 30 Apr 2019.