Trial Outcomes & Findings for Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery (NCT NCT00303901)
NCT ID: NCT00303901
Last Updated: 2020-07-22
Results Overview
Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
at 3, 6, and 12 months
Results posted on
2020-07-22
Participant Flow
Participant milestones
| Measure |
Cryosurgery
cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Cryosurgery
n=40 Participants
cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 3, 6, and 12 monthsLocal Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Outcome measures
| Measure |
Cryosurgery
n=40 Participants
cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography
|
|---|---|
|
Local Failure Rates by CT Scan
|
15 % of participants
Interval 7.0 to 29.0
|
PRIMARY outcome
Timeframe: at 3, 6, and 12 monthsDistant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Outcome measures
| Measure |
Cryosurgery
n=40 Participants
cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography
|
|---|---|
|
Distant Failure Rate
|
52.5 % of participants
Interval 37.0 to 67.0
|
SECONDARY outcome
Timeframe: at 3, 6, and 12 monthsRate of complications and adverse reactions by occurrences of toxicities as measured by the number of participants with a given category of toxicity.
Outcome measures
| Measure |
Cryosurgery
n=40 Participants
cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography
|
|---|---|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
DVT
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
atelectasis
|
3 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
constipation
|
2 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
contact dermatitis
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
deconditioning
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
depression
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
epigastric pain
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
fatigue
|
3 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
hemothorax
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
insomnia
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
muscle spasm
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
pain right side
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
severe atrial flutter
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Anemia
|
7 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Chest Wall Pain
|
21 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Cough
|
6 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Dyspnea
|
7 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Elevated AST
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Hemoptysis
|
8 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Hemorrhagic Effusion
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Hypotension
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Hypoxia
|
2 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Pleural Effusion
|
21 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Pneumothorax
|
21 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Pulmonary Hemorrhage
|
16 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
anxiety
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
blister
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
blurriness of vision
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
bradycardia
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
cardiac arrest
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
elevated ALT
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
headache
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
heartburn/dyspepsia
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
hepatic arteriovenous fistula
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
hyperglycemia
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
hypertension
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
ileus
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
infection
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
infection with normal ANC
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
low phosphorous
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
lymphopenia
|
3 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
nausea
|
2 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
pain
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
pneumonitis
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
progressive weakness
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
respiratory failure
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
subcutaneous hematoma
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
thrombocytopenia
|
1 Participants
|
|
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
vomiting
|
2 Participants
|
SECONDARY outcome
Timeframe: at 3, 6, and 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after the last patient was enrolledOutcome measures
Outcome data not reported
Adverse Events
Cryosurgery
Serious events: 9 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cryosurgery
n=40 participants at risk
cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography
|
|---|---|
|
Cardiac disorders
Cardiac Arrest
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Hepatic arteriovenous fistua
|
2.5%
1/40 • Number of events 1
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Progressive weakness
|
2.5%
1/40 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis (DVT)
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Deconditioning
|
2.5%
1/40 • Number of events 1
|
|
Cardiac disorders
Severe atrial flutter
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
Cryosurgery
n=40 participants at risk
cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.5%
3/40 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Fatigue
|
5.0%
2/40 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
17.5%
7/40 • Number of events 7
|
|
Cardiac disorders
Chest wall pain
|
52.5%
21/40 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
6/40 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.0%
6/40 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
20.0%
8/40 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
2/40 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
52.5%
21/40 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
52.5%
21/40 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hemorrhage
|
40.0%
16/40 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.0%
2/40 • Number of events 2
|
Additional Information
Peter Littrup, M.D.
Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8758
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place