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Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00843726
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Radiation: Arm 1 stereotactic body radiation therapy
Radiation: Arm II stereotactic body radiation therapy
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1 High-dose Fraction SBRT 3 High-dose Fractions SBRT
Hide Arm/Group Description

Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).

stereotactic body radiation therapy: Patients undergo 1 high-dose fraction

Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

stereotactic body radiation therapy: Patients undergo 3 high-dose fractions

Period Title: Overall Study
Started 49 49
Completed 48 48
Not Completed 1 1
Reason Not Completed
Death             1             0
Withdrawal by Subject             0             1
Arm/Group Title 1 High-dose Fraction SBRT 3 High-dose Fractions SBRT Total
Hide Arm/Group Description

Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).

stereotactic body radiation therapy: Patients undergo 1 high-dose fraction

Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

stereotactic body radiation therapy: Patients undergo 3 high-dose fractions

Total of all reporting groups
Overall Number of Baseline Participants 49 49 98
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
<=18 years
2
   4.1%
2
   4.1%
4
   4.1%
Between 18 and 65 years
2
   4.1%
7
  14.3%
9
   9.2%
>=65 years
45
  91.8%
40
  81.6%
85
  86.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 49 participants 98 participants
76.5  (7.5) 74.5  (8.0) 75.5  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
Female
27
  55.1%
23
  46.9%
50
  51.0%
Male
22
  44.9%
26
  53.1%
48
  49.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
American Indian or Alaska Native
1
   2.0%
0
   0.0%
1
   1.0%
Asian
1
   2.0%
0
   0.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   6.1%
3
   6.1%
6
   6.1%
White
41
  83.7%
43
  87.8%
84
  85.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   6.1%
3
   6.1%
6
   6.1%
1.Primary Outcome
Title Incidence of AE Grade 3 or Higher Toxicity
Hide Description Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse.
Time Frame 1year
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title I High-dose Fraction SBRT 3 High-dose Fractions SBRT
Hide Arm/Group Description:

Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).

stereotactic body radiation therapy: Patients undergo 1 high-dose fraction

Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

stereotactic body radiation therapy: Patients undergo 3 high-dose fractions

Overall Number of Participants Analyzed 49 49
Measure Type: Count of Participants
Unit of Measure: Participants
24
  49.0%
26
  53.1%
2.Primary Outcome
Title Overall Survival
Hide Description Median overall survival
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title 1 High-dose Fraction SBRT 3 High-dose Fractions SBRT
Hide Arm/Group Description:

Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).

stereotactic body radiation therapy: Patients undergo 1 high-dose fraction

Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

stereotactic body radiation therapy: Patients undergo 3 high-dose fractions

Overall Number of Participants Analyzed 49 49
Median (95% Confidence Interval)
Unit of Measure: months
39.0
(27.2 to 51.9)
38.3
(21.1 to 49.0)
3.Primary Outcome
Title Correlation Between Blood and Serum Markers and Survival and Toxicity
Hide Description [Not Specified]
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome
Arm/Group Title 1 High-dose Fraction SBRT 3 High-dose Fractions SBRT
Hide Arm/Group Description:

Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).

stereotactic body radiation therapy: Patients undergo 1 high-dose fraction

Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

stereotactic body radiation therapy: Patients undergo 3 high-dose fractions

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline, weekly until 30 day follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 High-dose Fraction SBRT 3 High-dose Fractions SBRT
Hide Arm/Group Description

Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).

stereotactic body radiation therapy: Patients undergo 1 high-dose fraction

Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

stereotactic body radiation therapy: Patients undergo 3 high-dose fractions

All-Cause Mortality
1 High-dose Fraction SBRT 3 High-dose Fractions SBRT
Affected / at Risk (%) Affected / at Risk (%)
Total   33/49 (67.35%)      29/49 (59.18%)    
Hide Serious Adverse Events
1 High-dose Fraction SBRT 3 High-dose Fractions SBRT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/49 (4.08%)      5/49 (10.20%)    
Infections and infestations     
Gastroenteritis   0/49 (0.00%)  0 1/49 (2.04%)  1
Lung infection   0/49 (0.00%)  0 1/49 (2.04%)  2
Pneumonia   0/49 (0.00%)  0 1/49 (2.04%)  1
Nervous system disorders     
Syncope   0/49 (0.00%)  0 1/49 (2.04%)  1
Renal and urinary disorders     
Acute kidney injury   0/49 (0.00%)  0 1/49 (2.04%)  1
Respiratory, thoracic and mediastinal disorders     
Cough   0/49 (0.00%)  0 1/49 (2.04%)  1
Dyspnoea   1/49 (2.04%)  1 1/49 (2.04%)  1
Dyspnoea exertional   1/49 (2.04%)  1 0/49 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 High-dose Fraction SBRT 3 High-dose Fractions SBRT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/49 (77.55%)      36/49 (73.47%)    
Blood and lymphatic system disorders     
Anaemia   2/49 (4.08%)  2 0/49 (0.00%)  0
Ear and labyrinth disorders     
Deafness   1/49 (2.04%)  1 0/49 (0.00%)  0
Vertigo   1/49 (2.04%)  1 0/49 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain   1/49 (2.04%)  1 1/49 (2.04%)  2
Abdominal pain upper   0/49 (0.00%)  0 1/49 (2.04%)  1
Constipation   1/49 (2.04%)  1 0/49 (0.00%)  0
Diarrhoea   2/49 (4.08%)  2 1/49 (2.04%)  1
Dysphagia   2/49 (4.08%)  2 3/49 (6.12%)  3
Haematochezia   1/49 (2.04%)  1 0/49 (0.00%)  0
Hiatus hernia   0/49 (0.00%)  0 1/49 (2.04%)  1
Intestinal obstruction   1/49 (2.04%)  1 0/49 (0.00%)  0
Nausea   3/49 (6.12%)  3 4/49 (8.16%)  4
Oesophageal stenosis   0/49 (0.00%)  0 1/49 (2.04%)  1
Rectal haemorrhage   0/49 (0.00%)  0 1/49 (2.04%)  1
Small intestinal obstruction   1/49 (2.04%)  1 0/49 (0.00%)  0
Vomiting   1/49 (2.04%)  1 3/49 (6.12%)  3
General disorders     
Asthenia   1/49 (2.04%)  1 0/49 (0.00%)  0
Chest discomfort   1/49 (2.04%)  1 0/49 (0.00%)  0
Chest pain   1/49 (2.04%)  1 3/49 (6.12%)  5
Chills   1/49 (2.04%)  1 0/49 (0.00%)  0
Disease progression   0/49 (0.00%)  0 1/49 (2.04%)  1
Fatigue   18/49 (36.73%)  21 21/49 (42.86%)  22
Oedema peripheral   0/49 (0.00%)  0 1/49 (2.04%)  1
Pain   1/49 (2.04%)  1 1/49 (2.04%)  1
Pyrexia   1/49 (2.04%)  2 2/49 (4.08%)  2
Infections and infestations     
Bronchitis   0/49 (0.00%)  0 2/49 (4.08%)  2
Cellulitis   0/49 (0.00%)  0 1/49 (2.04%)  1
Oral candidiasis   0/49 (0.00%)  0 1/49 (2.04%)  1
Orchitis   1/49 (2.04%)  1 0/49 (0.00%)  0
Pneumonia   3/49 (6.12%)  4 3/49 (6.12%)  3
Respiratory tract infection   0/49 (0.00%)  0 1/49 (2.04%)  1
Rhinitis   0/49 (0.00%)  0 1/49 (2.04%)  1
Sinusitis   1/49 (2.04%)  1 1/49 (2.04%)  1
Upper respiratory tract infection   0/49 (0.00%)  0 2/49 (4.08%)  2
Urinary tract infection   2/49 (4.08%)  2 0/49 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion   2/49 (4.08%)  2 0/49 (0.00%)  0
Fall   1/49 (2.04%)  1 2/49 (4.08%)  2
Hip fracture   1/49 (2.04%)  1 1/49 (2.04%)  2
Radiation pneumonitis   0/49 (0.00%)  0 1/49 (2.04%)  1
Rib fracture   1/49 (2.04%)  1 0/49 (0.00%)  0
Spinal compression fracture   0/49 (0.00%)  0 1/49 (2.04%)  1
Wrist fracture   1/49 (2.04%)  1 0/49 (0.00%)  0
Investigations     
Weight decreased   3/49 (6.12%)  3 4/49 (8.16%)  4
Metabolism and nutrition disorders     
Decreased appetite   3/49 (6.12%)  4 4/49 (8.16%)  4
Dehydration   1/49 (2.04%)  1 0/49 (0.00%)  0
Diabetes mellitus   1/49 (2.04%)  1 0/49 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain   4/49 (8.16%)  5 2/49 (4.08%)  2
Musculoskeletal discomfort   0/49 (0.00%)  0 1/49 (2.04%)  2
Musculoskeletal pain   0/49 (0.00%)  0 3/49 (6.12%)  3
Musculoskeletal stiffness   1/49 (2.04%)  1 0/49 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign salivary gland neoplasm   0/49 (0.00%)  0 1/49 (2.04%)  1
Nervous system disorders     
Dementia   0/49 (0.00%)  0 1/49 (2.04%)  1
Dizziness   2/49 (4.08%)  2 0/49 (0.00%)  0
Encephalopathy   0/49 (0.00%)  0 1/49 (2.04%)  1
Hypoaesthesia   0/49 (0.00%)  0 1/49 (2.04%)  1
Muscle contractions involuntary   0/49 (0.00%)  0 1/49 (2.04%)  1
Paraesthesia   0/49 (0.00%)  0 1/49 (2.04%)  1
Tremor   1/49 (2.04%)  1 0/49 (0.00%)  0
Psychiatric disorders     
Anxiety   0/49 (0.00%)  0 1/49 (2.04%)  1
Confusional state   1/49 (2.04%)  1 0/49 (0.00%)  0
Depression   0/49 (0.00%)  0 1/49 (2.04%)  1
Hallucination   1/49 (2.04%)  1 0/49 (0.00%)  0
Insomnia   0/49 (0.00%)  0 2/49 (4.08%)  2
Renal and urinary disorders     
Acute kidney injury   0/49 (0.00%)  0 1/49 (2.04%)  1
Micturition urgency   1/49 (2.04%)  1 0/49 (0.00%)  0
Pollakiuria   1/49 (2.04%)  1 0/49 (0.00%)  0
Renal pain   0/49 (0.00%)  0 1/49 (2.04%)  1
Reproductive system and breast disorders     
Breast pain   0/49 (0.00%)  0 1/49 (2.04%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease   1/49 (2.04%)  1 1/49 (2.04%)  1
Cough   8/49 (16.33%)  8 4/49 (8.16%)  4
Dysphonia   1/49 (2.04%)  1 1/49 (2.04%)  1
Dyspnoea   13/49 (26.53%)  16 11/49 (22.45%)  12
Dyspnoea exertional   1/49 (2.04%)  1 0/49 (0.00%)  0
Haemoptysis   1/49 (2.04%)  1 1/49 (2.04%)  1
Hypoxia   0/49 (0.00%)  0 1/49 (2.04%)  1
Painful respiration   0/49 (0.00%)  0 1/49 (2.04%)  1
Pleural effusion   0/49 (0.00%)  0 1/49 (2.04%)  1
Pneumonitis   1/49 (2.04%)  1 0/49 (0.00%)  0
Productive cough   0/49 (0.00%)  0 1/49 (2.04%)  1
Respiratory tract congestion   1/49 (2.04%)  1 0/49 (0.00%)  0
Sinus congestion   0/49 (0.00%)  0 1/49 (2.04%)  1
Upper-airway cough syndrome   0/49 (0.00%)  0 3/49 (6.12%)  3
Wheezing   2/49 (4.08%)  2 0/49 (0.00%)  0
Skin and subcutaneous tissue disorders     
Decubitus ulcer   0/49 (0.00%)  0 1/49 (2.04%)  1
Nail disorder   1/49 (2.04%)  1 0/49 (0.00%)  0
Pain of skin   0/49 (0.00%)  0 1/49 (2.04%)  1
Pruritus   1/49 (2.04%)  1 1/49 (2.04%)  1
Rash   1/49 (2.04%)  1 2/49 (4.08%)  2
Skin discolouration   0/49 (0.00%)  0 1/49 (2.04%)  1
Skin disorder   0/49 (0.00%)  0 1/49 (2.04%)  1
Skin ulcer   0/49 (0.00%)  0 1/49 (2.04%)  1
Telangiectasia   1/49 (2.04%)  1 0/49 (0.00%)  0
Vascular disorders     
Haematoma   1/49 (2.04%)  1 0/49 (0.00%)  0
Hypertension   0/49 (0.00%)  0 1/49 (2.04%)  1
Hypotension   2/49 (4.08%)  2 0/49 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 7168451300
EMail: adrienne.groman@roswellpark.org
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00843726    
Other Study ID Numbers: I 124407
I 124407 ( Other Identifier: Roswell Park Cancer Institute )
First Submitted: February 12, 2009
First Posted: February 13, 2009
Results First Submitted: April 15, 2021
Results First Posted: June 15, 2021
Last Update Posted: June 15, 2021