Image-guided Cryoablation of Head, Neck and Spine Tumors (NCT02085941) | Clinical Trial Compass
CompletedNot Applicable
Image-guided Cryoablation of Head, Neck and Spine Tumors
United States30 participantsStarted 2015-02
Plain-language summary
This research study is evaluating a procedure called cryoablation (the removal of diseased tissue using extreme freezing temperatures) as a possible treatment for head, neck and spine tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must meet the following criteria on screening examination to be eligible to participate in the study:
* Participants must have histologically confirmed malignant tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
* Participants with malignant locally recurrent and/or metastatic tumors will be eligible for cryoablation. All tumor shapes and sizes will be eligible for ablation.
* Participants must have sustained all available treatment options (radiation, chemotherapy, surgery) as verified by the Dana Farber Cancer Institute's Head and Neck Tumor Board. These cases will be reviewed by a team of medical oncologists, radiologists, radiation oncologists, and surgical oncologists.
* Participants must have an advanced head, neck or spine malignant tumor that would potentially benefit from a minimally invasive procedure.
* Age 18 years or older
\-- Because no dosing or adverse event data are currently available on the use of cryoablation in participants \< 18 years of age, children are excluded from this study but will be eligible for future pediatric III trials.
* Life expectancy of greater than 8 weeks in the opinion of the referring clinician.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).
* Participants must have normal organ and marrow function as defined below:
* Leukocytes ≥ 3,000/microliter (mcL)
* Absolute neu…
What they're measuring
1
Number of Participants Undergoing Image-guided Cryoablation of a Head, Neck, or Spine Tumor With Adverse Events