Cryosurgery for Early Stage Lung Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt-Ingram Cancer Center
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This clinical trial studies side effects and best treatment time of cryodevitalization in treating patients with early stage (stage I or stage II) lung cancer. Cryodevitalization is a type of cryosurgery that uses a flexible probe (cryoprobe) to kill tumor cells by freezing them. It is delivered at the time of standard diagnostic robotic bronchoscopy. Using cryodevitalization may be safe, tolerable and/or effective in treating patients with early stage lung cancer.
Will I have to stop taking my current medications?
The trial requires that you stop taking anticoagulants, clopidogrel, or other platelet aggregation inhibitors if you are currently prescribed them.
What data supports the effectiveness of the treatment Cryosurgery for Early Stage Lung Cancer?
Research shows that cryoablation, a type of cryosurgery, has been effective in treating early-stage non-small cell lung cancer (NSCLC), especially in patients who cannot undergo surgery. Studies have found that it can improve survival rates and reduce tumor markers in certain types of lung cancer.
12345Is cryosurgery safe for treating lung cancer?
Cryosurgery, also known as cryoablation or cryotherapy, has been used safely in treating advanced lung cancer, with studies focusing on its safety and common complications. It has been applied to lung tumors and primary lung cancer in older adults, showing a focus on safety and feasibility.
56789How is cryosurgery different from other treatments for early stage lung cancer?
Cryosurgery, also known as cryoablation or cryotherapy, is unique because it involves freezing cancer cells to kill them, which can be done through various routes like endobronchial or percutaneous. It is particularly suited for patients who cannot undergo surgery due to advanced disease, poor health, or those who refuse surgery, and it may also boost the immune system to fight cancer.
25101112Eligibility Criteria
This trial is for individuals with early stage (stage I or II) lung cancer. Participants should be suitable for cryosurgery and diagnostic procedures like robotic bronchoscopy, but specific inclusion and exclusion criteria are not provided.Inclusion Criteria
I am older than 18 years.
I have a small lung cancer nodule, confirmed during a procedure, with no spread to the middle chest area.
Exclusion Criteria
I am unable to understand or sign the consent form.
My initial lung exam showed possible cancer in my airways.
I have high blood pressure in the lungs.
I am currently taking blood thinners or medication to prevent blood clots.
Participant Groups
The CRYSTAL Trial is testing the timing and side effects of cryodevitalization—a procedure that freezes tumor cells—during standard diagnostic robotic bronchoscopy in patients with early stage lung cancer.
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment8 Interventions
Patients undergo 3 freeze-thaw cycles of cryodevitalization over 30 seconds or 3, 5, or 7 minutes each during standard of care robotic bronchoscopy with biopsy on study. Patients then undergo standard of care surgical resection on study. Patients also undergo a chest x-ray on study as well as CT and tissue sample collection throughout the study.
Cryodevitalization is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Cryotherapy for:
- Metastatic lung cancer
- Advanced lung cancer
- Symptomatic relief
🇺🇸 Approved in United States as Cryotherapy for:
- Early-stage lung cancer
- Metastatic lung cancer
- Symptomatic relief
🇨🇦 Approved in Canada as Cryotherapy for:
- Advanced lung cancer
- Symptomatic relief
🇯🇵 Approved in Japan as Cryotherapy for:
- Metastatic lung cancer
- Symptomatic relief
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Vanderbilt University/Ingram Cancer CenterNashville, TN
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Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
Swim Across AmericaCollaborator
Swim Across AmericaCollaborator
References
Five-year survival after cryoablation of stage I non-small cell lung cancer in medically inoperable patients. [2022]To evaluate retrospectively the long-term survival of patients with early-stage non-small cell lung cancer (NSCLC) treated with cryoablation.
Percutaneous cryoablation for the treatment of medically inoperable stage I non-small cell lung cancer. [2022]To evaluate the midterm results of percutaneous cryoablation for medically inoperable stage I non-small cell lung cancer.
Carcinoembryonic antigen as prognostic factor for metastatic non-small cell lung cancer by percutaneous cryosurgery. [2014]Carcinoembryonic antigen (CEA) is a prognostic marker for early-stage non-small cell lung cancer (NSCLC), and cryoablation is a new therapeutic alternative for lung cancer. We determined whether cryoablation-induced changes in serum CEA levels correlated with tumor type (adenocarcinoma or squamous carcinoma) and treatment type (comprehensive therapy [cryoablation of all intra- and extrapulmonary tumors] or palliative therapy [cryoablation of only extrapulmonary tumors]) in patients with metastatic NSCLC, and assessed whether pre-treatment CEA levels predicted overall survival (OS). We retrospectively reviewed the clinical data of 88 patients with metastatic NSCLC who underwent comprehensive (62 patients) or palliative (26 patients) therapy. Pre- and post-cryoablation serum CEA levels and overall survival were determined for all patients. Cryoablation significantly reduced CEA levels in adenocarcinoma, but not squamous carcinoma, patients. Among adenocarcinoma patients, the cryoablation-induced reduction in CEA levels was significantly greater after comprehensive treatment than after palliative treatment; the OS of patients under comprehensive cryoablation was longer than those under palliative treatment. Among adenocarcinoma patients receiving comprehensive cryoablation, OS was significantly longer in those with normal pre-treatment serum CEA levels than in those with abnormal pre-treatment serum CEA levels. Pretreatment level and change of serum CEA can be a good indicator for therapeutic effects and OS in metastatic NSCLC patients under percutaneous cryosurgery.
Percutaneous cryoablation for inoperable malignant lung tumors: midterm results. [2018]To retrospectively analyze the efficacy and short- to mid-term survival rate of cryoablation for malignant lung tumors.
Cryoablation for advanced non-small cell lung cancer: a protocol for a systematic review. [2021]National Comprehensive Cancer Network has recommended cryoablation to replace the resection in the treatment of medically operable non-small cell lung cancer (NSCLC). Cryoablation also has been used for the advanced NSCLC in randomised controlled trials. However, they have not been systematically reviewed. Here, we provide a protocol to evaluate the effectiveness and safety of cryoablation in the treatment of advanced NSCLC.
Percutaneous cryoablation of lung tumors: feasibility and safety. [2022]To evaluate the safety and feasibility of cryoablation for lung tumors as well as the incidence of, and risk factors for, complications.
[Complications of cryoablation in 644 lung cancer patients and its treatment]. [2023]Most lung cancer patients present an advanced stage at diagnosis without suitable surgical chances. Cryotherapy has been applied to the advanced lung cancer with safety and effectiveness. The aim of this study is to analyze the most common complications that occur after percutaneous cryoablation when applied to advanced lung cancer
Pulmonary Cryoablation Outcomes in Octogenarians and Nonagenarians with Primary Lung Cancer. [2023]To characterize the effectiveness, safety, and length of stay (LOS) associated with pulmonary cryoablation for management of primary lung malignancies in patients aged ≥80 years.
Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502). [2017]This single center prospective study is being conducted to evaluate the safety of the cryoablation for patients with pathologically diagnosed painful bone and soft tissue tumors. Enrollment of 10 patients is planned over the 3-year recruitment period. Patients have related local pain after receiving medications or external radiation therapies will be included in this study. Cryoablation will be percutaneously performed under imaging guidance, and a temperature sensor will be used during treatment as necessary. The primary endpoint is prevalence of severe adverse events within 4 weeks after therapy. The secondary endpoint is effectiveness 4 weeks after the procedure.
Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. [2022]Cryoablation of pulmonary metastases might be a useful therapy for nonsurgical candidates.
Cryosurgery for lung cancer. [2022]Cryosurgery is suited for patients with lung cancer who are not considered for lung resection because of the advanced stage of the disease or the patient's poor general condition or poor respiratory function and with tumor recurrence following radiotherapy, chemotherapy or lung resection, and those patients who have localized lung cancer but refuse to receive operative therapy. Procedures of cryosurgery for lung cancer can be performed through endobronchial, direct intrathoracic (at exploratory thoracotomy) or percutaneous routes depending upon location and size of tumor. Six hundred and twenty-five patients with Non-small cell lung cancer (NSCLC) received percutaneous cryoablation in Fuda Cancer Hospital Guangzhou, China. One hundred and fifty patients were followed-up for 12 to 38 months. Results showed that 1-, 2-, and 3-year survival rates were 64%, 45% and 32%, respectively. The adverse effects after cryosurgery of lung cancer include haemoptysis, pneumothorax, bloody thorax, pleural effusion and pulmonary infection which are generally mild, transient, and recovery with symptomatic management. In vitro studies have shown cryotherapy of lung cancer cells can improve the immune system to trigger the specific anti-tumor response. In the future, comparative studies between this modality and other therapies should be conducted for the treatment of lung cancer. In addition, more attention needs to be put on the immunomodulators that enhance the cryoimmunology.
Percutaneous imaging-guided cryoablation for lung cancer. [2020]Percutaneous cryoablation under imaging guidance has been proved to be a safe and effective method for ablation and debulking of tumors, providing radical cure or palliation, as the case may be, for patients with different stages of disease. The local control rate is high with cryoablation, and the complications are usually controllable, making it a reasonable choice in lung cancer treatment. In this paper the technique and mechanism of action of cryoablation are summarized, and studies performed on the application of percutaneous cryoablation in various stages of lung cancer are reviewed. Its emerging application in the treatment of pure ground-glass nodules (GGNs) is also introduced.