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

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

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 ≥ 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 This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000462091, WSU-C-2975, WSU-0509002942
Study First Received:	March 15, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00303901
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:

Respiratory Tract Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009