Trial Outcomes & Findings for Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis (NCT NCT00890617)
NCT ID: NCT00890617
Last Updated: 2022-11-01
Results Overview
Treatment success was defined as \> 75% of the resected ablated tissue showing no cancer on detailed histologic analysis. The primary statistical objective was to estimate the PCA success rate (p).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
3 weeks post-Percutaneous Cryotherapy (PTC)
Results posted on
2022-11-01
Participant Flow
Participant milestones
| Measure |
Prednisone & Cryotherapy
Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).
Prednisone: Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis
Baseline characteristics by cohort
| Measure |
Prednisone & Cryotherapy
n=9 Participants
Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).
Prednisone: Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
65.78 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeks post-Percutaneous Cryotherapy (PTC)Treatment success was defined as \> 75% of the resected ablated tissue showing no cancer on detailed histologic analysis. The primary statistical objective was to estimate the PCA success rate (p).
Outcome measures
| Measure |
Prednisone & Cryotherapy
n=9 Participants
Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).
Prednisone: Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
|
|---|---|
|
The Number of Patients With a Response (Complete Response and Partial Response)
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 months post-Percutaneous Cryotherapy (PTC)Histology samples from anterior, posterior, superior, inferior, medial and lateral areas of the resected tumor will be compared to enhancement zones of the ablation margin for any residual cancer.
Outcome measures
| Measure |
Prednisone & Cryotherapy
n=9 Participants
Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).
Prednisone: Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
|
|---|---|
|
The Number of Patients With a Pathologic Response
macroscopic residual viable tumor
|
1 Participants
|
|
The Number of Patients With a Pathologic Response
microscopic foci of viable tumor
|
2 Participants
|
|
The Number of Patients With a Pathologic Response
no microscopic viable tumor
|
6 Participants
|
Adverse Events
Prednisone & Cryotherapy
Serious events: 2 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Prednisone & Cryotherapy
n=9 participants at risk
Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).
Prednisone: Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
aspergillosis
|
11.1%
1/9 • Number of events 1 • over the first 6 months of study
CTCAE criteria
|
|
Cardiac disorders
atrial fibrillation
|
11.1%
1/9 • Number of events 1 • over the first 6 months of study
CTCAE criteria
|
Other adverse events
| Measure |
Prednisone & Cryotherapy
n=9 participants at risk
Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).
Prednisone: Prednisone taken:
20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
|
|---|---|
|
Cardiac disorders
atrial fibrillation
|
22.2%
2/9 • Number of events 2 • over the first 6 months of study
CTCAE criteria
|
|
Infections and infestations
pneumonia
|
22.2%
2/9 • Number of events 2 • over the first 6 months of study
CTCAE criteria
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
33.3%
3/9 • Number of events 3 • over the first 6 months of study
CTCAE criteria
|
|
Injury, poisoning and procedural complications
vocal cord dysfunction
|
22.2%
2/9 • Number of events 2 • over the first 6 months of study
CTCAE criteria
|
Additional Information
Dr. Frank A. Baciewicz
Barbara Ann Karmanos Cancer Institute
Phone: (313) 993-0580
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place