Non Small Cell Lung CancerNCT02950337
Stereotactic Body Radiation Therapy for Un-biopsied Early- Stage Non Small Cell Lung Cancer
A study testing Group 1: Peripherally Located Tumors, Group 2: Peripherally Located Chest Wall Adjacent Tumors and Group 3: Centrally Located Tumors in people with Non Small Cell Lung Cancer, run by Loyola University at 2 sites in United States.
Trial summary
Lung cancer is the leading cause of cancer death in both men and women in the United States. In 2014, an estimated 224,210 men and women were diagnosed with carcinoma of the lung and bronchus, resulting in 159,260 deaths. 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?
- Group 1: Peripherally Located Tumors, Group 2: Peripherally Located Chest Wall Adjacent Tumors and Group 3: Centrally Located Tumors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2015to Dec 2023
- Phase
- Interventional
- 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
- • Presence of parenchymal lung nodule, without pathological diagnosis, highly suspicious for NSCLC as defined by at least one of the criteria below. Validated clinical prediction model estimates probability of malignancy is ≥ 85% or
- Multidisciplinary tumor board determines patient's history, clinical findings, and radiographic findings are consistent with high probability of malignancy.
- Medically-inoperable patient due to one of the criteria below
- Poor pulmonary function for resection including baseline Forced Expiratory Volume in 1 second (FEV1), FEV1 <50%, post-operative predicted FEV1<30% predicted, diffusion capacity <50%, baseline hypoxemia and/or hypercapnia. Patients with severe obstructive or restrictive lung disease will be eligible for inclusion.
- Pulmonary hypertension
- Cerebral, cardiac, or peripheral vascular disease
Show all 28Show fewer
- Chronic heart disease
- Diabetes mellitus with end organ damage
- Age ≥75
- Patient declines surgery
- Absence of pathological diagnosis due to one of the criteria below
- High risk of complications from transbronchial or transthoracic biopsy
- Biopsy was performed or attempted but with complications requiring abortion of procedure
- Biopsy was performed and non-diagnostic for malignancy but without other diagnosis to explain the clinical and radiographic findings
- Patient declines biopsy Stage T1-3, N0, M0 (AJCC Staging, 7th Ed.) based upon the following diagnostic workup
- History/Physical examination by an experienced thoracic cancer clinician (thoracic surgeon, interventional pulmonologist, medical oncologist, or radiation oncologist) within 4 weeks prior to registration
- Diagnostic imaging (CT and/or PET/CT) Serial computed tomography and/or positron emission tomography imaging clinically consistent with lung malignancy.
- CT scan with contrast (unless medically contraindicated) within 6 weeks of registration. The tumor dimensions will be measured on CT with greatest dimension ≤5cm.
- Whole body Positron Emission Tomography / Computerized Tomography (PET/CT) within 12 weeks of registration. Standard uptake value (SUV) must be available but no minimum SUV is required for inclusion.
- No clinical or radiographic evidence of nodal disease or distant metastases No previous local therapy such as external beam radiotherapy, lobectomy, or sublobar resection.
- Women of child-bearing potential must undergo pregnancy testing prior to enrollment on study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months.
- Patients with prior history of malignancy are permitted registration but must not be undergoing active cytotoxic or biologically-targeted therapy, must be disease-free from any malignancy for the previous three years, and must not have any history of brain metastases with the following exceptions:
- Patients with history of basal cell carcinoma and/or squamous cell carcinoma may be permitted access within 3 years of being disease-free and is up to the discretion of the treating physicians
- Patients with any prior history of lung cancer may not participate in this study.
- Age ≥ 18 years. Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- • Prior history of lung cancer.
- Prior local therapy (surgery or radiotherapy) for the current, clinically-diagnosed NSCLC.
- Patients receiving any other investigational agents.
- Patients with a known history of malignancy with a disease-free interval <3 years prior to enrollment or a history of brain metastases
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that could limit compliance with study requirements.
- Patients who are currently pregnant or nursing due to the potential for congenital abnormalities and potential harm to nursing infants.
- Patients enrolled on a competing investigational study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Edward Hines Jr, VA Hospital
Hines, Illinois, 60141
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: Phase II Study of Stereotactic Body Radiation Therapy for Un-biopsied Early- Stage Non Small Cell Lung Cancer
Lung cancer is the leading cause of cancer death in both men and women in the United States. In 2014, an estimated 224,210 men and women were diagnosed with carcinoma of the lung and bronchus, resulting in 159,260 deaths. Per the current National Comprehensive Cancer Network (NCCN) guidelines, the standard of care for early-stage non-small cell lung cancer (NSCLC) is lobectomy with lymph node dissection. Historically, medically inoperable early-stage NSCLC patients have been offered definitive external beam radiotherapy (EBRT) as primary management but, overall, studies have consistently shown poor patient outcomes. Stereotactic body radiation therapy (SBRT) is a technique which delivers very high doses of radiation per fraction over one to five fractions to precisely defined volumes with steep dose gradients. SBRT is commonly utilized for the treatment of biopsy-proven early stage NSCLC in the medically inoperable patient.
Read the detailed description
This purpose of this study is to learn about the good and bad effects of treating early stage lung cancer without having a biopsy of the tumor. Participants in this research will receive a type of radiation treatment called Stereotactic Body Radiation Therapy (SBRT). This type of radiation is targeted directly at the tumor so that damage to surrounding normal tissue can be avoided. SBRT is often used in treating patients with biopsy proven early stage lung cancer who cannot have surgery for medical reasons. In this study, SBRT is considered experimental because the tumor has not been biopsied. SBRT for early-stage NSCLC has consistently proven to provide excellent local control and improved overall survival in the medically inoperable patient. The constancy of this finding over a variety of dose schedules confirms the robustness of SBRT. This study will utilize 54 Gy in 3 fractions delivered twice weekly for peripheral lesions. In order to respect the increased risk of adverse events our dose for centrally located lesions will be reduced to 50 Gy in 5 fractions delivered twice weekly and for chest wall or rib adjacent lesions will be 60 Gy in 5 fractions. These doses are consistent with Radiation Therapy Oncology Group (RTOG) 0236 for peripheral lesions and RTOG 0813 for central lesions and are both ≥100 Gy Biological Effective Dose (BED) as previously discussed . The investigators of this study routinely prescribe 60 Gy in 5 fractions for rib adjacent lesions.
The primary objective is to assess acute and chronic toxicities associated with SBRT of unbiopsied early-stage NSCLC.
Secondary objectives include:
To evaluate the disease specific outcomes of local control, lobar failure-free survival, regional/nodal failure-free survival, distant metastasis-free survival, disease-free survival, cause-specific survival, and overall survival associated with SBRT of unbiopsied early-stage NSCLC patients.
To evaluate Pulmonary Function Test (PFT) changes over time following SBRT of unbiopsied early-stage NSCLC patients.
To evaluate the patient's overall quality of life before and after treatment with SBRT of unbiopsied early-stage NSCLC patients.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Group 1: Peripherally Located Tumors, Group 2: Peripherally Located Chest Wall Adjacent Tumors, Group 3: Centrally Located Tumors
- Keywords
- Unbiopsied Early Stage Non Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Peripherally Located TumorsRadiation
Group 1: For peripherally located tumors patients will receive SBRT(Stereotactic Body Radiation Therapy) , 3 fractions of 18 Gy to a total dose of 54 Gy, with a minimum of 40 hours between each treatment fraction is required. ( Gy = Gray and is the unit used to measure the total amount of radiation a patient is exposed to)
Group 2: Peripherally Located Chest Wall Adjacent TumorsRadiation
Group 2: For chest wall adjacent tumors patients will receive SBRT (Stereotactic Body Radiation Therapy) , 5 fractions of 12 Gy to a total dose of 60 Gy, with a minimum of 40 hours between each treatment fraction is required. ( Gy = Gray and is the unit used to measure the total amount of radiation a patient is exposed to)
Group 3: Centrally Located TumorsRadiation
Group 3: For central tumors patients will receive SBRT (Stereotactic Body Radiation Therapy) , 5 fractions of 10 Gy to a total dose of 50 Gy, with a minimum of 40 hours between each treatment fraction is required. ( Gy = Gray and is the unit used to measure the total amount of radiation a patient is exposed to)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Peripherally Located Tumors | Experimental | Peripherally Located Tumors - SBRT Receives: Radiation: Group 1: Peripherally Located Tumors |
| Group 2: Peripherally Located Chest Wall Adjacent Tumors | Experimental | Peripherally Located Chest Wall Adjacent Tumors - SBRT Receives: Radiation: Group 2: Peripherally Located Chest Wall Adjacent Tumors |
| Group 3: Centrally Located Tumors | Experimental | Centrally Located Tumors - SBRT Receives: Radiation: Group 3: Centrally Located Tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity Evaluation
Radiation related acute and chronic pulmonary grade 3-5 toxicity as defined by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 Toxicity evaluations will be done at weekly on treatment visits and at follow up visits for up to 104 weeks.
Measured: 104 weeks
Secondary outcomes (1)
Disease Specific Outcomes
Patients will be classified at week 104 as having (1) disappearance of the treated lesion (i.e., complete response), (2) at least 30% decrease in the diameter of the treated lesion (i.e., partial response), (3) at least 20% increase in the diameter of the treated lesion (i.e., progressive disease), or (4) Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (i.e., stable disease). Disease outcomes will be assessed during follow up exams up to 104 weeks.
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Harkenrider, Loyola University
- Investigators
- Matthew Harkenrider, MD, Principal investigator, Loyola UniversityMatthew Harkenrider, MD, Principal investigator, Edward Hines Jr. VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950337
- Sponsor's protocol ID
- 208111
- Other IDs
- 208111102115
- Status last verified
- Dec 2023
- First submitted
- 9 Sep 2016
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7.
PubMed 24399786Qiao X, Tullgren O, Lax I, Sirzen F, Lewensohn R. The role of radiotherapy in treatment of stage I non-small cell lung cancer. Lung Cancer. 2003 Jul;41(1):1-11. doi: 10.1016/s0169-5002(03)00152-1.
PubMed 12826306Dosoretz DE, Katin MJ, Blitzer PH, Rubenstein JH, Salenius S, Rashid M, Dosani RA, Mestas G, Siegel AD, Chadha TT, et al. Radiation therapy in the management of medically inoperable carcinoma of the lung: results and implications for future treatment strategies. Int J Radiat Oncol Biol Phys. 1992;24(1):3-9. doi: 10.1016/0360-3016(92)91013-d.
PubMed 1324899Sibley GS, Jamieson TA, Marks LB, Anscher MS, Prosnitz LR. Radiotherapy alone for medically inoperable stage I non-small-cell lung cancer: the Duke experience. Int J Radiat Oncol Biol Phys. 1998 Jan 1;40(1):149-54. doi: 10.1016/s0360-3016(97)00589-0.
PubMed 9422571Zierhut D, Bettscheider C, Schubert K, van Kampen M, Wannenmacher M. Radiation therapy of stage I and II non-small cell lung cancer (NSCLC). Lung Cancer. 2001 Dec;34 Suppl 3:S39-43. doi: 10.1016/s0169-5002(01)00381-6.
PubMed 11740992Kupelian PA, Komaki R, Allen P. Prognostic factors in the treatment of node-negative nonsmall cell lung carcinoma with radiotherapy alone. Int J Radiat Oncol Biol Phys. 1996 Oct 1;36(3):607-13. doi: 10.1016/s0360-3016(96)00364-1.
PubMed 8948345Kaskowitz L, Graham MV, Emami B, Halverson KJ, Rush C. Radiation therapy alone for stage I non-small cell lung cancer. Int J Radiat Oncol Biol Phys. 1993 Oct 20;27(3):517-23. doi: 10.1016/0360-3016(93)90374-5.
PubMed 8226143Fakiris AJ, McGarry RC, Yiannoutsos CT, Papiez L, Williams M, Henderson MA, Timmerman R. Stereotactic body radiation therapy for early-stage non-small-cell lung carcinoma: four-year results of a prospective phase II study. Int J Radiat Oncol Biol Phys. 2009 Nov 1;75(3):677-82. doi: 10.1016/j.ijrobp.2008.11.042. Epub 2009 Feb 27.
PubMed 19251380Timmerman R, Paulus R, Galvin J, Michalski J, Straube W, Bradley J, Fakiris A, Bezjak A, Videtic G, Johnstone D, Fowler J, Gore E, Choy H. Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA. 2010 Mar 17;303(11):1070-6. doi: 10.1001/jama.2010.261.
PubMed 20233825Takeda A, Kunieda E, Sanuki N, Aoki Y, Oku Y, Handa H. Stereotactic body radiotherapy (SBRT) for solitary pulmonary nodules clinically diagnosed as lung cancer with no pathological confirmation: comparison with non-small-cell lung cancer. Lung Cancer. 2012 Jul;77(1):77-82. doi: 10.1016/j.lungcan.2012.01.006. Epub 2012 Jan 31.
PubMed 22300750Ricardi U, Filippi AR, Guarneri A, Giglioli FR, Ciammella P, Franco P, Mantovani C, Borasio P, Scagliotti GV, Ragona R. Stereotactic body radiation therapy for early stage non-small cell lung cancer: results of a prospective trial. Lung Cancer. 2010 Apr;68(1):72-7. doi: 10.1016/j.lungcan.2009.05.007. Epub 2009 Jun 24.
PubMed 19556022Gould MK, Maclean CC, Kuschner WG, Rydzak CE, Owens DK. Accuracy of positron emission tomography for diagnosis of pulmonary nodules and mass lesions: a meta-analysis. JAMA. 2001 Feb 21;285(7):914-24. doi: 10.1001/jama.285.7.914.
PubMed 11180735Gould MK, Donington J, Lynch WR, Mazzone PJ, Midthun DE, Naidich DP, Wiener RS. Evaluation of individuals with pulmonary nodules: when is it lung cancer? Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e93S-e120S. doi: 10.1378/chest.12-2351.
PubMed 23649456Herder GJ, van Tinteren H, Golding RP, Kostense PJ, Comans EF, Smit EF, Hoekstra OS. Clinical prediction model to characterize pulmonary nodules: validation and added value of 18F-fluorodeoxyglucose positron emission tomography. Chest. 2005 Oct;128(4):2490-6. doi: 10.1378/chest.128.4.2490.
PubMed 16236914Harkenrider MM, Bertke MH, Dunlap NE. Stereotactic body radiation therapy for unbiopsied early-stage lung cancer: a multi-institutional analysis. Am J Clin Oncol. 2014 Aug;37(4):337-42. doi: 10.1097/COC.0b013e318277d822.
PubMed 23660597
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Stereotactic Body Radiation Therapy for Un-biopsied Early- Stage Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02950337
- Acronym / sponsor ID
- 208111
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Unbiopsied Early Stage Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is the leading cause of cancer death in both men and women in the United States. In 2014, an estimated 224,210 men and women were diagnosed with carcinoma of the lung and bronchus, resulting in 159,260 deaths. Per the current National Comprehensive Cancer Network (NCCN) guidelines, the standard of care for early-stage non-small cell lung cancer (NSCLC) is lobectomy with lymph node dissection. Historically, medically inoperable early-stage NSCLC patients have been offered definitive external beam radiotherapy (EBRT) as primary management but, overall, studies have consistently shown poor patient outcomes. Stereotactic body radiation therapy (SBRT) is a technique which delivers very high doses of radiation per fraction over one to five fractions to precisely defined volumes with steep dose gradients. SBRT is commonly utilized for the treatment of biopsy-proven early stage NSCLC in the medically inoperable patient.
Detailed description
This purpose of this study is to learn about the good and bad effects of treating early stage lung cancer without having a biopsy of the tumor. Participants in this research will receive a type of radiation treatment called Stereotactic Body Radiation Therapy (SBRT). This type of radiation is targeted directly at the tumor so that damage to surrounding normal tissue can be avoided. SBRT is often used in treating patients with biopsy proven early stage lung cancer who cannot have surgery for medical reasons. In this study, SBRT is considered experimental because the tumor has not been biopsied. SBRT for early-stage NSCLC has consistently proven to provide excellent local control and improved overall survival in the medically inoperable patient. The constancy of this finding over a variety of dose schedules confirms the robustness of SBRT. This study will utilize 54 Gy in 3 fractions delivered twice weekly for peripheral lesions. In order to respect the increased risk of adverse events our dose for centrally located lesions will be reduced to 50 Gy in 5 fractions delivered twice weekly and for chest wall or rib adjacent lesions will be 60 Gy in 5 fractions. These doses are consistent with Radiation Therapy Oncology Group (RTOG) 0236 for peripheral lesions and RTOG 0813 for central lesions and are both ≥100 Gy Biological Effective Dose (BED) as previously discussed . The investigators of this study routinely prescribe 60 Gy in 5 fractions for rib adjacent lesions.
The primary objective is to assess acute and chronic toxicities associated with SBRT of unbiopsied early-stage NSCLC.
Secondary objectives include:
To evaluate the disease specific outcomes of local control, lobar failure-free survival, regional/nodal failure-free survival, distant metastasis-free survival, disease-free survival, cause-specific survival, and overall survival associated with SBRT of unbiopsied early-stage NSCLC patients.
To evaluate Pulmonary Function Test (PFT) changes over time following SBRT of unbiopsied early-stage NSCLC patients.
To evaluate the patient's overall quality of life before and after treatment with SBRT of unbiopsied early-stage NSCLC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Peripherally Located Tumors | Experimental | Radiation: Group 1: Peripherally Located TumorsPeripherally Located Tumors - SBRT |
| Group 2: Peripherally Located Chest Wall Adjacent Tumors | Experimental | Radiation: Group 2: Peripherally Located Chest Wall Adjacent TumorsPeripherally Located Chest Wall Adjacent Tumors - SBRT |
| Group 3: Centrally Located Tumors | Experimental | Radiation: Group 3: Centrally Located TumorsCentrally Located Tumors - SBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- • Presence of parenchymal lung nodule, without pathological diagnosis, highly suspicious for NSCLC as defined by at least one of the criteria below. Validated clinical prediction model estimates probability of malignancy is ≥ 85% or
- Medically-inoperable patient due to one of the criteria below
- Poor pulmonary function for resection including baseline Forced Expiratory Volume in 1 second (FEV1), FEV1 <50%, post-operative predicted FEV1<30% predicted, diffusion capacity <50%, baseline hypoxemia and/or hypercapnia. Patients with severe obstructive or restrictive lung disease will be eligible for inclusion.
- Pulmonary hypertension
- Cerebral, cardiac, or peripheral vascular disease
Key exclusion criteria (7 listed)
- • Prior history of lung cancer.
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 |
|---|---|---|
| Group 1: Peripherally Located TumorsGroup 1: For peripherally located tumors patients will receive SBRT(Stereotactic Body Radiation Therapy) , 3 fractions of 18 Gy to a total dose of 54 Gy, with a minimum of 40 hours between each treatment fraction is required. ( Gy = Gray and is the unit used to measure the total amount of radiation a patient is exposed to) | Radiation | Group 1: Peripherally Located Tumors |
| Group 2: Peripherally Located Chest Wall Adjacent TumorsGroup 2: For chest wall adjacent tumors patients will receive SBRT (Stereotactic Body Radiation Therapy) , 5 fractions of 12 Gy to a total dose of 60 Gy, with a minimum of 40 hours between each treatment fraction is required. ( Gy = Gray and is the unit used to measure the total amount of radiation a patient is exposed to) | Radiation | Group 2: Peripherally Located Chest Wall Adjacent Tumors |
| Group 3: Centrally Located TumorsGroup 3: For central tumors patients will receive SBRT (Stereotactic Body Radiation Therapy) , 5 fractions of 10 Gy to a total dose of 50 Gy, with a minimum of 40 hours between each treatment fraction is required. ( Gy = Gray and is the unit used to measure the total amount of radiation a patient is exposed to) | Radiation | Group 3: Centrally Located Tumors |
Primary outcome
Toxicity Evaluation
Time frame: 104 weeks
Radiation related acute and chronic pulmonary grade 3-5 toxicity as defined by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 Toxicity evaluations will be done at weekly on treatment visits and at follow up visits for up to 104 weeks.
1 secondary outcome
Disease Specific Outcomes
Time frame: 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Results publication: PubMed 24399786Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7.
- Results publication: PubMed 12826306Qiao X, Tullgren O, Lax I, Sirzen F, Lewensohn R. The role of radiotherapy in treatment of stage I non-small cell lung cancer. Lung Cancer. 2003 Jul;41(1):1-11. doi: 10.1016/s0169-5002(03)00152-1.
- Results publication: PubMed 1324899Dosoretz DE, Katin MJ, Blitzer PH, Rubenstein JH, Salenius S, Rashid M, Dosani RA, Mestas G, Siegel AD, Chadha TT, et al. Radiation therapy in the management of medically inoperable carcinoma of the lung: results and implications for future treatment strategies. Int J Radiat Oncol Biol Phys. 1992;24(1):3-9. doi: 10.1016/0360-3016(92)91013-d.
- Results publication: PubMed 9422571Sibley GS, Jamieson TA, Marks LB, Anscher MS, Prosnitz LR. Radiotherapy alone for medically inoperable stage I non-small-cell lung cancer: the Duke experience. Int J Radiat Oncol Biol Phys. 1998 Jan 1;40(1):149-54. doi: 10.1016/s0360-3016(97)00589-0.
- Results publication: PubMed 11740992Zierhut D, Bettscheider C, Schubert K, van Kampen M, Wannenmacher M. Radiation therapy of stage I and II non-small cell lung cancer (NSCLC). Lung Cancer. 2001 Dec;34 Suppl 3:S39-43. doi: 10.1016/s0169-5002(01)00381-6.
- Results publication: PubMed 8948345Kupelian PA, Komaki R, Allen P. Prognostic factors in the treatment of node-negative nonsmall cell lung carcinoma with radiotherapy alone. Int J Radiat Oncol Biol Phys. 1996 Oct 1;36(3):607-13. doi: 10.1016/s0360-3016(96)00364-1.
- Results publication: PubMed 8226143Kaskowitz L, Graham MV, Emami B, Halverson KJ, Rush C. Radiation therapy alone for stage I non-small cell lung cancer. Int J Radiat Oncol Biol Phys. 1993 Oct 20;27(3):517-23. doi: 10.1016/0360-3016(93)90374-5.
- Results publication: PubMed 19251380Fakiris AJ, McGarry RC, Yiannoutsos CT, Papiez L, Williams M, Henderson MA, Timmerman R. Stereotactic body radiation therapy for early-stage non-small-cell lung carcinoma: four-year results of a prospective phase II study. Int J Radiat Oncol Biol Phys. 2009 Nov 1;75(3):677-82. doi: 10.1016/j.ijrobp.2008.11.042. Epub 2009 Feb 27.
- Results publication: PubMed 20233825Timmerman R, Paulus R, Galvin J, Michalski J, Straube W, Bradley J, Fakiris A, Bezjak A, Videtic G, Johnstone D, Fowler J, Gore E, Choy H. Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA. 2010 Mar 17;303(11):1070-6. doi: 10.1001/jama.2010.261.
- Results publication: PubMed 22300750Takeda A, Kunieda E, Sanuki N, Aoki Y, Oku Y, Handa H. Stereotactic body radiotherapy (SBRT) for solitary pulmonary nodules clinically diagnosed as lung cancer with no pathological confirmation: comparison with non-small-cell lung cancer. Lung Cancer. 2012 Jul;77(1):77-82. doi: 10.1016/j.lungcan.2012.01.006. Epub 2012 Jan 31.
- Results publication: PubMed 19556022Ricardi U, Filippi AR, Guarneri A, Giglioli FR, Ciammella P, Franco P, Mantovani C, Borasio P, Scagliotti GV, Ragona R. Stereotactic body radiation therapy for early stage non-small cell lung cancer: results of a prospective trial. Lung Cancer. 2010 Apr;68(1):72-7. doi: 10.1016/j.lungcan.2009.05.007. Epub 2009 Jun 24.
- Results publication: PubMed 11180735Gould MK, Maclean CC, Kuschner WG, Rydzak CE, Owens DK. Accuracy of positron emission tomography for diagnosis of pulmonary nodules and mass lesions: a meta-analysis. JAMA. 2001 Feb 21;285(7):914-24. doi: 10.1001/jama.285.7.914.
- Individual participant dataSharing planned: No
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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.
Matthew Harkenrider, MD principal investigator
Loyola University
Matthew Harkenrider, MD principal investigator
Edward Hines Jr. VA Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: Peripherally Located Tumors, Group 2: Peripherally Located Chest Wall Adjacent Tumors and Group 3: Centrally Located Tumors in people with Non Small Cell Lung Cancer, run by Loyola University at 2 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?
The sponsor lists 28 inclusion and 7 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 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Toxicity Evaluation (time frame: 104 weeks). 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 NCT02950337, which also lists 17 linked publications.
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 21 Dec 2023.