Clinical trial NCT00303901: Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
Official title: Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Local Failure Rates by CT Scan
timeFrame: at 3, 6, and 12 months
measure: Distant Failure Rate
timeFrame: at 3, 6, and 12 months
Secondary outcomes:
measure: Rate of Complications and Adverse Reactions by Occurrences of Toxicities
timeFrame: at 3, 6, and 12 months
measure: Correlate Procedural Parameters and Follow-up Imaging Parameters
timeFrame: at 3, 6, and 12 months
measure: Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures
timeFrame: 12 months after the last patient was enrolled
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Peter J. Littrup, MD
role: STUDY_CHAIR
References: