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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Metastatic Cancer
• Intervention / Treatment: Procedure: positron emission tomography; Procedure: cryosurgery

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201-1379
      • Barbara Ann Karmanos Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: positron emission tomography; Procedure: cryosurgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 3, 6, and 12 months
Correlate Procedural Parameters and Follow-up Imaging Parameters		at 3, 6, and 12 months
Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures		12 months after the last patient was enrolled

Collaborators and Investigators

• Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: March 15, 2006
• First Submitted That Met QC Criteria: March 15, 2006
• First Posted (Estimate): March 17, 2006

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; extensive stage small cell lung cancer; recurrent 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; stage I non-small cell lung cancer; stage II non-small cell lung cancer; limited stage small cell lung cancer; lung metastases; pulmonary carcinoid tumor
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CDR0000462091; P30CA022453 (U.S. NIH Grant/Contract); WSU-C-2975; WSU-0509002942