Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery

• Sponsor: Barbara Ann Karmanos Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00303901
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 67.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery.

PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be removed by surgery.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Metastatic Cancer	Procedure: cryosurgery; Procedure: positron emission tomography	N/A

Detailed Description

OBJECTIVES:

• Estimate the local and distant failure rates after percutaneous thoracic cryotherapy (PTC) in patients with unresectable primary lung cancer or lung metastases.

• Estimate rates of PTC complications and adverse reactions.

• Determine the correlations between procedural parameters and follow-up imaging parameters, with the latter being used as surrogates of local and/or distant treatment failure.

OUTLINE: Patients undergo CT-guided percutaneous thoracic cryotherapy over 2 hours under local or general anesthesia. Grouped cryoprobes are inserted into the tumor, utilizing a freeze-thaw-freeze cycle, creating cytotoxic temperatures (less than -20°C to -40°C) that encompass the entire anticipated tumor volume.

Patients undergo positron emission tomography at baseline and after cryotherapy to assess tumor standard uptake variable.

After completion of study treatment, patients are followed at 1, 3, 6 and 12 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: cryosurgery; Procedure: positron emission tomography

Outcome Measures

Primary Outcome Measures

1. Local Failure Rates by CT Scan [at 3, 6, and 12 months]

   Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence

2. Distant Failure Rate [at 3, 6, and 12 months]

   Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence

Secondary Outcome Measures

1. Rate of Complications and Adverse Reactions by Occurrences of Toxicities [at 3, 6, and 12 months]

   Rate of complications and adverse reactions by occurrences of toxicities as measured by the number of participants with a given category of toxicity.

2. Correlate Procedural Parameters and Follow-up Imaging Parameters [at 3, 6, and 12 months]

3. Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures [12 months after the last patient was enrolled]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed malignant pulmonary neoplasm

• New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed

• Imaging findings compatible with localized treatment failure after prior cryotherapy allowed

• Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy

• Metastatic disease must meet all of the following criteria:

• Primary tumors have been resected or have been deemed controlled by other therapies

• No other widespread metastases evident (e.g., multiple hepatic or brain metastases)

• Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach

• No more than 5 targeted masses for study therapy

• Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1 cm, but < 10 cm in average diameter

• Unresectable disease by surgical consultation OR patient refused surgical options

• Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm increments with available soft tissue and mediastinal windows to assess size and extent of all thoracic tumors

• PET scan required within the past 6 months noting the correlation with the above CT locations, if not already obtained by a combined PET/CT scanner

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) > 60-100% OR WHO/ECOG/Zubrod PS 0-2

• FEV_1 > 30% of predicted

• DLCO > 40% of predicted

• Platelet count ≥ 70,000/mm^3

• INR < 1.5

• No uncontrolled coagulopathy or bleeding diathesis

• Not pregnant or nursing

• Negative pregnancy test

• No serious medical illness, including any of the following:

• Uncontrolled congestive heart failure

• Uncontrolled angina

• Myocardial infarction

• Cerebrovascular event within 6 months prior to study entry

• No medical contraindication or potential problem that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• At least 7 days since prior aspirin and aspirin-like medications

• At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds

• No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or clopidogrel bisulfate)

• No concurrent participation in other experimental studies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379

Sponsors and Collaborators

• Barbara Ann Karmanos Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Study Chair: Peter J. Littrup, MD, Barbara Ann Karmanos Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical trial summary from the National Cancer Institute's PDQ® database

Publications

None provided.

• Responsible Party: Peter John Littrup, Principal Investigator, Barbara Ann Karmanos Cancer Institute
• ClinicalTrials.gov Identifier: NCT00303901
• Other Study ID Numbers: CDR0000462091; P30CA022453; WSU-C-2975; WSU-0509002942
• First Posted: Mar 17, 2006
• Last Update Posted: Jul 22, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Peter John Littrup, Principal Investigator, Barbara Ann Karmanos Cancer Institute: lung metastases; recurrent non-small cell lung cancer; recurrent small cell lung cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; extensive stage small cell lung cancer; limited stage small cell lung cancer; pulmonary carcinoid tumor
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

Participant Flow

Arm/Group Title	Cryosurgery
Arm/Group Description	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
Period Title: Overall Study
STARTED	40
COMPLETED	40
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cryosurgery
Arm/Group Description	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 Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 47.5%
>=65 years	21 52.5%
Sex: Female, Male (Count of Participants)
Female	20 50%
Male	20 50%
Region of Enrollment (participants) [Number]
United States	40 100%

Outcome Measures

1. Primary Outcome

Title	Local Failure Rates by CT Scan
Description	Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Time Frame	at 3, 6, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cryosurgery
Arm/Group Description	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
Measure Participants	40
Number (95% Confidence Interval) [% of participants]	15 37.5%

2. Primary Outcome

Title	Distant Failure Rate
Description	Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Time Frame	at 3, 6, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cryosurgery
Arm/Group Description	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
Measure Participants	40
Number (95% Confidence Interval) [% of participants]	52.5 131.3%

3. Secondary Outcome

Title	Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Description	Rate of complications and adverse reactions by occurrences of toxicities as measured by the number of participants with a given category of toxicity.
Time Frame	at 3, 6, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cryosurgery
Arm/Group Description	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
Measure Participants	40
DVT	1 2.5%
atelectasis	3 7.5%
constipation	2 5%
contact dermatitis	1 2.5%
deconditioning	1 2.5%
depression	1 2.5%
epigastric pain	1 2.5%
fatigue	3 7.5%
hemothorax	1 2.5%
insomnia	1 2.5%
muscle spasm	1 2.5%
pain right side	1 2.5%
severe atrial flutter	1 2.5%
Anemia	7 17.5%
Chest Wall Pain	21 52.5%
Cough	6 15%
Dyspnea	7 17.5%
Elevated AST	1 2.5%
Hemoptysis	8 20%
Hemorrhagic Effusion	1 2.5%
Hypotension	1 2.5%
Hypoxia	2 5%
Pleural Effusion	21 52.5%
Pneumothorax	21 52.5%
Pulmonary Hemorrhage	16 40%
anxiety	1 2.5%
blister	1 2.5%
blurriness of vision	1 2.5%
bradycardia	1 2.5%
cardiac arrest	1 2.5%
elevated ALT	1 2.5%
headache	1 2.5%
heartburn/dyspepsia	1 2.5%
hepatic arteriovenous fistula	1 2.5%
hyperglycemia	1 2.5%
hypertension	1 2.5%
ileus	1 2.5%
infection	1 2.5%
infection with normal ANC	1 2.5%
low phosphorous	1 2.5%
lymphopenia	3 7.5%
nausea	2 5%
pain	1 2.5%
pneumonitis	1 2.5%
progressive weakness	1 2.5%
respiratory failure	1 2.5%
subcutaneous hematoma	1 2.5%
thrombocytopenia	1 2.5%
vomiting	2 5%

4. Secondary Outcome

Title	Correlate Procedural Parameters and Follow-up Imaging Parameters
Time Frame	at 3, 6, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures
Time Frame	12 months after the last patient was enrolled

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Cryosurgery
Arm/Group Description	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
All Cause Mortality
	Cryosurgery
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cryosurgery
	Affected / at Risk (%)	# Events
Total	9/40 (22.5%)
Cardiac disorders
Cardiac Arrest	1/40 (2.5%)	1
Severe atrial flutter	1/40 (2.5%)	1
General disorders
Deconditioning	1/40 (2.5%)	1
Infections and infestations
Infection with normal ANC	1/40 (2.5%)	1
Musculoskeletal and connective tissue disorders
Progressive weakness	1/40 (2.5%)	1
Renal and urinary disorders
Hepatic arteriovenous fistua	1/40 (2.5%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/40 (2.5%)	1
Pleural effusion	1/40 (2.5%)	1
Vascular disorders
Hypertension	1/40 (2.5%)	1
Deep vein thrombosis (DVT)	1/40 (2.5%)	1
Other (Not Including Serious) Adverse Events
	Cryosurgery
	Affected / at Risk (%)	# Events
Total	38/40 (95%)
Blood and lymphatic system disorders
Lymphopenia	3/40 (7.5%)	3
Anemia	7/40 (17.5%)	7
Cardiac disorders
Chest wall pain	21/40 (52.5%)	21
Gastrointestinal disorders
Nausea	2/40 (5%)	2
Vomiting	2/40 (5%)	2
General disorders
Fatigue	2/40 (5%)	2
Respiratory, thoracic and mediastinal disorders
Cough	6/40 (15%)	6
Dyspnea	6/40 (15%)	6
Hemoptysis	8/40 (20%)	8
Hypoxia	2/40 (5%)	2
Pleural Effusion	21/40 (52.5%)	21
Pneumothorax	21/40 (52.5%)	21
Pulmonary Hemorrhage	16/40 (40%)	16
Atelectasis	2/40 (5%)	2

Limitations/Caveats

There were no study limitations.

More Information

Certain Agreements

All Principal Investigators ARE 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.