Stereotactic Body Radiation Therapy for Un-biopsied Early- Stage Non Small Cell Lung Cancer
NCT ID: NCT02950337
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
41 participants
INTERVENTIONAL
2015-12-31
2023-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1: Peripherally Located Tumors
Peripherally Located Tumors - SBRT
Group 1: Peripherally Located Tumors
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 Tumors
Peripherally Located Chest Wall Adjacent Tumors - SBRT
Group 2: Peripherally Located Chest Wall Adjacent Tumors
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 Tumors
Centrally Located Tumors - SBRT
Group 3: Centrally Located Tumors
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)
Interventions
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Group 1: Peripherally Located Tumors
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 Tumors
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 Tumors
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Loyola University
OTHER
Responsible Party
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Matthew Harkenrider
Assistant Professor, Residency Program Director & Director of Brachytherapy
Principal Investigators
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Matthew Harkenrider, MD
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Matthew Harkenrider, MD
Role: PRINCIPAL_INVESTIGATOR
Edward Hines Jr. VA Hospital
Locations
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Edward Hines Jr, VA Hospital
Hines, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Countries
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References
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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.
Qiao 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.
Dosoretz 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.
Sibley 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.
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Kupelian 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.
Kaskowitz 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.
Fakiris 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.
Timmerman 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.
Takeda 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.
Ricardi 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.
Gould 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.
Gould 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.
Herder 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.
Harkenrider 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.
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Dunlap NE, Cai J, Biedermann GB, Yang W, Benedict SH, Sheng K, Schefter TE, Kavanagh BD, Larner JM. Chest wall volume receiving >30 Gy predicts risk of severe pain and/or rib fracture after lung stereotactic body radiotherapy. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):796-801. doi: 10.1016/j.ijrobp.2009.02.027. Epub 2009 May 8.
Other Identifiers
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208111102115
Identifier Type: OTHER
Identifier Source: secondary_id
208111
Identifier Type: -
Identifier Source: org_study_id