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

NCT ID: NCT00303901

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2011-07-31

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.

Conditions

Lung Cancer; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

cryosurgery

Intervention Type: PROCEDURE

positron emission tomography

Intervention Type: PROCEDURE

Interventions

cryosurgery

Intervention Type: PROCEDURE

positron emission tomography

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Peter John Littrup

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter J. Littrup, MD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-C-2975

Identifier Type: -

Identifier Source: secondary_id

WSU-0509002942

Identifier Type: -

Identifier Source: secondary_id

CDR0000462091

Identifier Type: -

Identifier Source: org_study_id