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

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Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2007
Sponsors and Collaborators: Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00303901

Purpose
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.



Condition Intervention
Lung Cancer
Metastatic Cancer
Procedure: cryosurgery
Procedure: positron emission tomography




MedlinePlus related topics: Cancer Lung Cancer Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Local and distant failure rates by CT scan at 3, 6, and 12 months [ Designated as safety issue: No ]



Secondary Outcome Measures:
Rate of complications and adverse reactions by occurrences of toxicities at 3, 6, and 12 months [ Designated as safety issue: Yes ]

Correlate procedural parameters and follow-up imaging parameters at 3, 6, and 12 months [ Designated as safety issue: No ]

Point and exact confidence interval estimates of patients who undergo multiple cryotherapy procedures [ Designated as safety issue: No ]


Estimated Enrollment: 40
Study Start Date: November 2005
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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 &#8805; 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
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303901


Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Peter J. Littrup, MD Barbara Ann Karmanos Cancer Institute

More Information


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

Study ID Numbers: CDR0000462091, WSU-C-2975, WSU-0509002942
Study First Received: March 15, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00303901 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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



Study placed in the following topic categories:
Carcinoid tumor
Thoracic Neoplasms
Carcinoma, Small Cell
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Carcinoid Tumor
Carcinoma, Non-Small-Cell Lung
Recurrence



Additional relevant MeSH terms:
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Respiratory Tract Neoplasms
Neoplasms



ClinicalTrials.gov processed this record on February 10, 2009


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