Trial Outcomes & Findings for Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery (NCT NCT00499447)
NCT ID: NCT00499447
Last Updated: 2019-05-08
Results Overview
the number of patients surviving progression-free at two years.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
2 years
Results posted on
2019-05-08
Participant Flow
Participants were recruited from the Radiation Oncology Clinic at the Comprehensive Cancer Center of Wake Forest University.
Participant milestones
| Measure |
Radiofrequency Ablation Combined With External
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Radiofrequency Ablation Combined With External
n=13 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsthe number of patients surviving progression-free at two years.
Outcome measures
| Measure |
Radiofrequency Ablation Combined With External
n=13 Participants
|
|---|---|
|
Two Year Progression Free Survival Rate
|
8 participants
|
Adverse Events
Radiofrequency Ablation Combined With External
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiofrequency Ablation Combined With External
n=12 participants at risk
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Number of events 2
|
|
Investigations
Carbon monoxide diffusion
|
33.3%
4/12 • Number of events 4
|
|
Investigations
hyperglycemia
|
16.7%
2/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
decreased forced expiratory volume
|
25.0%
3/12 • Number of events 3
|
|
Investigations
Lymphopenia
|
33.3%
4/12 • Number of events 4
|
|
Infections and infestations
Lung infection
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Burn
|
8.3%
1/12 • Number of events 1
|
Other adverse events
| Measure |
Radiofrequency Ablation Combined With External
n=12 participants at risk
|
|---|---|
|
Investigations
Low WBC
|
25.0%
3/12 • Number of events 3
|
|
Investigations
low Platelets
|
25.0%
3/12 • Number of events 3
|
|
Investigations
Low Hemoglobin
|
66.7%
8/12 • Number of events 11
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Anorexia
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Alkaline phosphatase
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Urinary retention (including neurogenic bladder)
|
8.3%
1/12 • Number of events 1
|
|
Reproductive system and breast disorders
Dyspnea
|
33.3%
4/12 • Number of events 5
|
|
Investigations
Carbon monoxide diffusion
|
66.7%
8/12 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
25.0%
3/12 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
33.3%
4/12 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
25.0%
3/12 • Number of events 3
|
|
General disorders
Hypertension
|
16.7%
2/12 • Number of events 2
|
|
Nervous system disorders
Neuropathy: motor
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Low ANC
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Insomnia
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Rigors/chills
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Sweating
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Fatigue
|
41.7%
5/12 • Number of events 6
|
|
Investigations
hyperglycemia
|
66.7%
8/12 • Number of events 10
|
|
Investigations
hypoglycemia
|
16.7%
2/12 • Number of events 2
|
|
Investigations
hypocalcemia
|
16.7%
2/12 • Number of events 2
|
|
Investigations
hypomagnesemia
|
8.3%
1/12 • Number of events 1
|
|
Investigations
hyponatremia
|
8.3%
1/12 • Number of events 1
|
|
Investigations
hypokalemia
|
16.7%
2/12 • Number of events 2
|
|
Investigations
hypoalbuminemia
|
33.3%
4/12 • Number of events 4
|
|
Investigations
hyperbilirubinemia
|
8.3%
1/12 • Number of events 1
|
|
Investigations
serum glutamic oxaloacetic transaminase
|
8.3%
1/12 • Number of events 1
|
|
Investigations
hypernatremia
|
8.3%
1/12 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Ocular/Visual - Other
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Dysphagia
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Fever without neutropenia
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
6/12 • Number of events 7
|
|
Vascular disorders
Edema: limb
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Heartburn/dyspepsia
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Hypoxia
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Partial Thromboplastin Time
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Ataxia
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Pain: Back
|
16.7%
2/12 • Number of events 2
|
|
Investigations
Amylase
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
"Fistula, pulmonary/upper respiratory: Bronchus"
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm wheezing
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Pain: Chest/thorax
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Pain: Chest wall
|
41.7%
5/12 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
decreased forced expiratory volume
|
75.0%
9/12 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
8.3%
1/12 • Number of events 1
|
|
Investigations
hypertriglyceridemia
|
8.3%
1/12 • Number of events 1
|
|
Immune system disorders
Injection site reaction
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Lymphopenia
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Memory impairment
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Pain: Muscle
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Nail changes
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Ulcer Esophagus
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Esophagitis
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
50.0%
6/12 • Number of events 6
|
|
Vascular disorders
Hemorrhage Lung
|
16.7%
2/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Soft tissue necrosis Thorax
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Vital capacity
|
16.7%
2/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Infection with unknown ANC Lung (pneumonia)
|
8.3%
1/12 • Number of events 1
|
Additional Information
Dr. James Urbanic
Comprehensive Cancer Center of Wake Forest University
Phone: 336-713-3600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place