This trial is active, not recruiting.

Conditions lung cancer, metastatic cancer
Treatments cryosurgery, positron emission tomography
Sponsor Barbara Ann Karmanos Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date November 2005
End date July 2013
Trial size 41 participants
Trial identifier NCT00303901, CDR0000462091, P30CA022453, WSU-0509002942, WSU-C-2975


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
positron emission tomography

Primary Outcomes

Local and distant failure rates by CT scan
time frame: at 3, 6, and 12 months

Secondary Outcomes

Rate of complications and adverse reactions by occurrences of toxicities
time frame: at 3, 6, and 12 months
Correlate procedural parameters and follow-up imaging parameters
time frame: at 3, 6, and 12 months
Point and exact confidence interval estimates of patients who undergo multiple cryotherapy procedures
time frame: 12 months after the last patient was enrolled

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute.