Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Lung Cancer
Interventions:	Radiation: SBRT 40.0 Gy; Radiation: SBRT 42.5 Gy; Radiation: SBRT 45.0 Gy; Radiation: SBRT 47.5 Gy; Radiation: SBRT 50.0 Gy; Radiation: SBRT 52.5 Gy; Radiation: SBRT 55.0 Gy; Radiation: SBRT 57.5 Gy; Radiation: SBRT 60.0 Gy

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was designed to start at dose level 5. Dose levels 1-4 were in place only to be used if the regimen in general proved too toxic and lower dose levels were needed. No patients were accrued to levels 1-4.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Level 5: 10.0 Gy/FX	SBRT 50.0 Gy SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
Level 6: 10.5 Gy/FX	SBRT 52.5 Gy SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
Level 7: 11.0 Gy/FX	SBRT 55.0 Gy SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
Level 8: 11.5 Gy/FX	SBRT 57.5 Gy SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy
Level 9: 12.0 Gy/FX	SBRT 60.0 Gy SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Participant Flow:   Overall Study

	Level 5: 10.0 Gy/FX	Level 6: 10.5 Gy/FX	Level 7: 11.0 Gy/FX	Level 8: 11.5 Gy/FX	Level 9: 12.0 Gy/FX
STARTED	8	8	18	43	43
COMPLETED	8 [1]	7	14	38	33
NOT COMPLETED	0	1	4	5	10
Protocol Violation	0	1	1	2	4
Withdrawal by Subject	0	0	2	2	2
Physician Decision	0	0	0	0	2
Patient too large for positioning	0	0	1	0	0
Site error	0	0	0	1	0
SBRT plan could not be drawn	0	0	0	0	1
Fiducials could not be placed	0	0	0	0	1

[1]	Subjects contributing data to the primary analysis are considered to have completed the study

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible patients receiving protocol treatment

Reporting Groups

	Description
Level 5: 10.0 Gy/FX	SBRT 50.0 Gy SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
Level 6: 10.5 Gy/FX	SBRT 52.5 Gy SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
Level 7: 11.0 Gy/FX	SBRT 55.0 Gy SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
Level 8: 11.5 Gy/FX	SBRT 57.5 Gy SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy
Level 9: 12.0 Gy/FX	SBRT 60.0 Gy SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy
Total	Total of all reporting groups

Baseline Measures

	Level 5: 10.0 Gy/FX	Level 6: 10.5 Gy/FX	Level 7: 11.0 Gy/FX	Level 8: 11.5 Gy/FX	Level 9: 12.0 Gy/FX	Total
Overall Participants Analyzed; [Units: Participants]	8	7	14	38	33	100
Age; [Units: Years]; Median (Full Range)	74; (59 to 81)	75; (53 to 89)	72; (59 to 81)	71; (52 to 87)	72; (55 to 89)	72; (52 to 89)
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	6 75.0%	3 42.9%	6 42.9%	15 39.5%	13 39.4%	43 43.0%
Male	2 25.0%	4 57.1%	8 57.1%	23 60.5%	20 60.6%	57 57.0%

  Outcome Measures

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1. Primary:

(Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 [ Time Frame: From start of SBRT to 1 year ]

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2. Primary:

(Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD) [ Time Frame: From start of SBRT to 2 years. ]

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3. Secondary:

Progression-free Survival [ Time Frame: From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. ]

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4. Secondary:

Overall Survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. ]

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5. Secondary:

Local Progression [ Time Frame: From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months. ]

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6. Secondary:

Nodal Progression [ Time Frame: From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. ]

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7. Secondary:

Distant Metastases [ Time Frame: From randomization to date of death, distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. ]

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8. Secondary:

Rate of Toxicity ≥ Grade 3 (Other Than DLT) Within One Year as Assessed by NCI CTCAE v4.0 [ Time Frame: From start of SBRT until 1 year. ]

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9. Secondary:

Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0 [ Time Frame: From start of treatment to end of follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.

Results Point of Contact:  

Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Péchoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032.

Responsible Party:	Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:	NCT00750269 History of Changes
Obsolete Identifiers:	NCT01317056
Other Study ID Numbers:	RTOG-0813; CDR0000613524; NCI-2009-01095 ( Registry Identifier: CTRP (Clinical Trials Reporting Program) )
First Submitted:	September 9, 2008
First Posted:	September 10, 2008
Results First Submitted:	June 30, 2016
Results First Posted:	May 10, 2017
Last Update Posted:	April 23, 2018