Stereotactic Body Radiation Therapy for Un-biopsied Early- Stage Non Small Cell Lung Cancer

NCT02950337 | Unknown DMC

• 2 other identifiers: 208111208111102115
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Non Small Cell Lung Cancer

Keywords

Unbiopsied Early Stage Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  104 weeks

Secondary Outcomes (1)

• Disease Specific Outcomes

  104 weeks

Study Arms (3)

Group 1: Peripherally Located Tumors

EXPERIMENTAL

Peripherally Located Tumors - SBRT

Radiation: Group 1: Peripherally Located Tumors

Group 2: Peripherally Located Chest Wall Adjacent Tumors

EXPERIMENTAL

Peripherally Located Chest Wall Adjacent Tumors - SBRT

Radiation: Group 2: Peripherally Located Chest Wall Adjacent Tumors

Group 3: Centrally Located Tumors

EXPERIMENTAL

Centrally Located Tumors - SBRT

Radiation: Group 3: Centrally Located Tumors

Interventions

Group 1: Peripherally Located Tumors RADIATION

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 1: Peripherally Located Tumors

Group 2: Peripherally Located Chest Wall Adjacent Tumors RADIATION

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 2: Peripherally Located Chest Wall Adjacent Tumors

Group 3: Centrally Located Tumors RADIATION

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)

Group 3: Centrally Located Tumors

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (2)

Edward Hines Jr, VA Hospital

Hines, Illinois, 60141, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (17)

• 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.

  PMID: 24399786 RESULT

• 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.

  PMID: 12826306 RESULT

• 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.

  PMID: 1324899 RESULT

• 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.

  PMID: 9422571 RESULT

• Zierhut 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.

  PMID: 11740992 RESULT

• 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.

  PMID: 8948345 RESULT

• 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.

  PMID: 8226143 RESULT

• 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.

  PMID: 19251380 RESULT

• 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.

  PMID: 20233825 RESULT

• 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.

  PMID: 22300750 RESULT

• 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.

  PMID: 19556022 RESULT

• 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.

  PMID: 11180735 RESULT

• 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.

  PMID: 23649456 RESULT

• 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.

  PMID: 16236914 RESULT

• 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.

  PMID: 23660597 RESULT

• Timmerman RD. An overview of hypofractionation and introduction to this issue of seminars in radiation oncology. Semin Radiat Oncol. 2008 Oct;18(4):215-22. doi: 10.1016/j.semradonc.2008.04.001. No abstract available.

  PMID: 18725106 RESULT

• 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.

  PMID: 19427740 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthew Harkenrider, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

• Matthew Harkenrider, MD

  Edward Hines Jr. VA Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Residency Program Director & Director of Brachytherapy

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: November 1, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)