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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303901
• Other study ID #: CDR0000462091
• Secondary ID: P30CA022453WSU-C
• Status: Completed
• Phase: N/A
• Start date: November 2005
• Est. completion date: July 2011

Study information

• Verified date: July 2020
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer

Intervention

Procedure:
• cryosurgery

• positron emission tomography

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Distant Failure Rate	Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence	at 3, 6, and 12 months
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.	at 3, 6, and 12 months
Secondary	Correlate Procedural Parameters and Follow-up Imaging Parameters		at 3, 6, and 12 months
Secondary	Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures		12 months after the last patient was enrolled

External Links

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