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

Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00303901
Enrollment
40
Registered
2006-03-17
Start date
2005-11-30
Completion date
2011-07-31
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Metastatic Cancer

Keywords

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

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.

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.

Interventions

PROCEDUREcryosurgery
PROCEDUREpositron emission tomography

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Local Failure Rates by CT Scanat 3, 6, and 12 monthsLocal Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Distant Failure Rateat 3, 6, and 12 monthsDistant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence

Secondary

MeasureTime frameDescription
Rate of Complications and Adverse Reactions by Occurrences of Toxicitiesat 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.
Correlate Procedural Parameters and Follow-up Imaging Parametersat 3, 6, and 12 months
Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures12 months after the last patient was enrolled

Countries

United States

Participant flow

Participants by arm

ArmCount
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
40
Total40

Baseline characteristics

CharacteristicCryosurgery
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
21 Participants
Age, Categorical
Between 18 and 65 years
19 Participants
Region of Enrollment
United States
40 participants
Sex: Female, Male
Female
20 Participants
Sex: Female, Male
Male
20 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
38 / 40
serious
Total, serious adverse events
9 / 40

Outcome results

Primary

Distant Failure Rate

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

Time frame: at 3, 6, and 12 months

ArmMeasureValue (NUMBER)
CryosurgeryDistant Failure Rate52.5 % of participants
Primary

Local Failure Rates by CT Scan

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

Time frame: at 3, 6, and 12 months

ArmMeasureValue (NUMBER)
CryosurgeryLocal Failure Rates by CT Scan15 % of participants
Secondary

Correlate Procedural Parameters and Follow-up Imaging Parameters

Time frame: at 3, 6, and 12 months

Secondary

Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures

Time frame: 12 months after the last patient was enrolled

Secondary

Rate of Complications and Adverse Reactions by Occurrences of Toxicities

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesDVT1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesatelectasis3 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesconstipation2 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiescontact dermatitis1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesdeconditioning1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesdepression1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesepigastric pain1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesfatigue3 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitieshemothorax1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesinsomnia1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesmuscle spasm1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiespain right side1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiessevere atrial flutter1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesAnemia7 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesChest Wall Pain21 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesCough6 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesDyspnea7 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesElevated AST1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesHemoptysis8 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesHemorrhagic Effusion1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesHypotension1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesHypoxia2 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesPleural Effusion21 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesPneumothorax21 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of ToxicitiesPulmonary Hemorrhage16 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesanxiety1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesblister1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesblurriness of vision1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesbradycardia1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiescardiac arrest1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitieselevated ALT1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesheadache1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesheartburn/dyspepsia1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitieshepatic arteriovenous fistula1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitieshyperglycemia1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitieshypertension1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesileus1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesinfection1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesinfection with normal ANC1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitieslow phosphorous1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitieslymphopenia3 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesnausea2 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiespain1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiespneumonitis1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesprogressive weakness1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesrespiratory failure1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiessubcutaneous hematoma1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesthrombocytopenia1 Participants
CryosurgeryRate of Complications and Adverse Reactions by Occurrences of Toxicitiesvomiting2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026