Trials / Withdrawn
WithdrawnNCT01325753
Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body
A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This pilot clinical trial studies the side effects of cryotherapy (cryoablation \[CA\]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.
Detailed description
PRIMARY OBJECTIVES: I. Assess the initial safety of the CA for lung tumors less than or equal to 3.5 cm in size including acute toxicity (30 days). SECONDARY OBJECTIVES: I. Estimate local control. II. To assess physical function for this cohort of patients. III. To evaluate the impact of treatment on generic and disease-specific quality of life. IV. To obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial. V. Evaluate changes in pulmonary function at 3 months. OUTLINE: Patients undergo computed tomography (CT)-guided CA After completion of study treatment, patients are followed up at 1 week and 1, 3, 6, 12, 24, 36, 48, and 60 months.
Conditions
- Advanced Malignant Mesothelioma
- Extensive Stage Small Cell Lung Cancer
- Lung Metastases
- Recurrent Malignant Mesothelioma
- Recurrent Non-small Cell Lung Cancer
- Recurrent Small Cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | cryotherapy | Undergo CT-guided CA |
| PROCEDURE | quality-of-life assessment | Ancillary studies |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2013-03-01
- Completion
- 2017-03-01
- First posted
- 2011-03-30
- Last updated
- 2018-07-03
Source: ClinicalTrials.gov record NCT01325753. Inclusion in this directory is not an endorsement.