|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery | ||||
| Official Title † | Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management | ||||
| 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:
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 Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Local and distant failure rates by CT scan at 3, 6, and 12 months [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | 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 ] |
||||
| Condition † | Lung Cancer Metastatic Cancer |
||||
| Intervention † | Procedure: cryosurgery Procedure: positron emission tomography |
||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 40 | ||||
| Start Date † | November 2005 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00303901 | ||||
| Organization ID | CDR0000462091 | ||||
| Secondary IDs †† | WSU-C-2975, WSU-0509002942 | ||||
| Study Sponsor † | Barbara Ann Karmanos Cancer Institute | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2007 | ||||
| First Received Date † | March 15, 2006 | ||||
| Last Updated Date | July 23, 2008 | ||||