Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer

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ClinicalTrials.gov Identifier: NCT01656460

Recruitment Status : Completed

First Posted : August 3, 2012

Results First Posted : July 24, 2015

Last Update Posted : July 22, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Memorial Hospital of Rhode Island

Information provided by (Responsible Party):

Dr Thomas DiPetrillo, Brown University

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: Stereotactic radiation Arm 1 Radiation: Stereotactic radiation Arm 2 Radiation: Stereotactic radiation Arm 3 Radiation: Stereotactic radiation Arm 4
Enrollment	12

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Stereotactic Radiation Dose Level 1	Stereotactic Radiation Dose Level 2	Stereotactic Radiation Dose Level 3	Stereotactic Radiation Dose Level 4
Arm/Group Description	Radiation: Stereotactic radiation A...	Radiation: Stereotactic radiation A...	Radiation: Stereotactic radiation A...	Radiation: Stereotactic radiation A...
Arm/Group Description	Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy	Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy	Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy	Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
Period Title: Overall Study
Started	3	3	3	3
Completed	3	3	3	3
Not Completed	0	0	0	0

Baseline Characteristics

Arm/Group Title		Stereotactic Radiation
Arm/Group Description		stereotactic
Arm/Group Description		stereotactic
Overall Number of Baseline Participants		12
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	12 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	5 41.7%
	>=65 years	7 58.3%
Age, Continuous Mean (Full Range) Unit of measure: Years
	Number Analyzed	12 participants
		63.9 (32 to 76)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	12 participants
	Female	4 33.3%
	Male	8 66.7%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	12 participants
United States		12

Outcome Measures

1.Primary Outcome


Title	Early and Intermediate Toxicity for Dose Limiting Toxicity
Description	Any toxicity related to the radiation treatment will be scored and gra...
Description	Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm 1-Stereotactic Radiation Dose Level 1	Arm 2-Stereotactic Radiation Dose Level 2	Arm 3-Stereotactic Radiation Dose Level 3	Arm 4-Stereotactic Radiation Dose Level 4
Arm/Group Description:	Radiation: Stereotactic radiation A...	Radiation: Stereotactic radiation A...	Radiation: Stereotactic radiation A...	Radiation: Stereotactic radiation A...
Arm/Group Description:	Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy	Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy	Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy	Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
Overall Number of Participants Analyzed	3	3	3	3
Measure Type: Number Unit of Measure: participants
	0	0	0	0

Adverse Events

Time Frame	Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Arm 1-Stereotactic Radiation Dose Level 1		Arm 2-Stereotactic Radiation Dose Level 2		Arm 3-Stereotactic Radiation Dose Level 3		Arm 4-Stereotactic Radiation Dose Level 4
Arm/Group Description	Radiation: Stereotactic radiation A...		Radiation: Stereotactic radiation A...		Radiation: Stereotactic radiation A...		Radiation: Stereotactic radiation A...
Arm/Group Description	Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy		Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy		Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy		Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
All-Cause Mortality
	Arm 1-Stereotactic Radiation Dose Level 1		Arm 2-Stereotactic Radiation Dose Level 2		Arm 3-Stereotactic Radiation Dose Level 3		Arm 4-Stereotactic Radiation Dose Level 4
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	Arm 1-Stereotactic Radiation Dose Level 1		Arm 2-Stereotactic Radiation Dose Level 2		Arm 3-Stereotactic Radiation Dose Level 3		Arm 4-Stereotactic Radiation Dose Level 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.33%)		0/3 (0.00%)		1/3 (33.33%)		2/3 (66.67%)
Investigations
K(3), AKI secondary to cisplatin nephrotoxicity(5) ^† [1]	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0
AKI(2) RT poor intake, CR(2) RT poor intake, Fatigue (2) RT pneumonia or chemo, H/A(2) related ^†	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
hypoglycemia(2), chest pain (3), Hyperglycemia(3), HGB(2), CR(1) k(1) ^† [2]	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
Dyspnea 4, Tachycardia 2, Fever 1cough 1- ^† [3]	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
Bronchopulmonary Hemorrhage (5) ^† [4]	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0
upper respiratory infection ^† [5]	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
URI (3) rt chemo, PLT(2) PR chemo, hyponatremia (3) PR chemo, bilateral thigh pain(2) suspected ^†	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
† Indicates events were collected by systematic assessment [1] not related to study [2] ALL events unrelated to SBRT and related to patients underlying medical history [3] all unlikely related to SBRT [4] likely related to SBRT as late toxicity [5] NOT r/t SBRT.Pt #13: fever(3),AKI(1),dyspnea(3),URI(3),Lung Infection Influenza A(3), Productive cough(1) F/u: MG(3),PLT(1),AKI(1),CR(1),nausea(1),dizziness(1), leukocytosis(3),hypoxia, URI (3) F/U #2 pneumonia(3)&influzena (3)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm 1-Stereotactic Radiation Dose Level 1		Arm 2-Stereotactic Radiation Dose Level 2		Arm 3-Stereotactic Radiation Dose Level 3		Arm 4-Stereotactic Radiation Dose Level 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100.00%)		2/3 (66.67%)		3/3 (100.00%)		3/3 (100.00%)
Investigations
HgB ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	2/3 (66.67%)	2
vomiting ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
Creatinine ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0
WBC ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	2/3 (66.67%)	2	0/3 (0.00%)	0
Thrombocytopenia ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0
dermatitis ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0
pleural effusion ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0
Lymph ^†	1/3 (33.33%)	1	1/3 (33.33%)	1	2/3 (66.67%)	2	3/3 (100.00%)	3
Bili ^†	0/3 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0
dyspnea/hypoxia ^†	0/3 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0
myalgia ^†	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	1/3 (33.33%)	1
esophagitis ^†	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0
K ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	1/3 (33.33%)	1	1/3 (33.33%)	1
ANC ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0
cough ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	2/3 (66.67%)	2
fatigue ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
pain- thigh/leg/groin/chest wall ^†	1/3 (33.33%)	1	1/3 (33.33%)	1	0/3 (0.00%)	0	1/3 (33.33%)	1
nausea ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0
Ca ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0
pneumonitis ,upper respiratory infection (URI),lung Infection (influenza A) ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
AST ^†	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	2/3 (66.67%)	2
ALT ^†	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
Magnesium ^†	1/3 (33.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0
fever ^†	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
diarrhea ^†	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
chills ^†	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
edema ^†	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
aspiration ^†	0/3 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Thomas DiPetrillo, MD
Organization:	Brown University Oncology Research Group (BrUOG)
Phone:	4018633000
EMail:	kayla_rosati@brown.edu

Layout table for additonal information

Responsible Party:	Dr Thomas DiPetrillo, Brown University
ClinicalTrials.gov Identifier:	NCT01656460
Other Study ID Numbers:	BrUOG 259
First Submitted:	July 24, 2012
First Posted:	August 3, 2012
Results First Submitted:	June 29, 2015
Results First Posted:	July 24, 2015
Last Update Posted:	July 22, 2020

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