Status:
COMPLETED
The Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Liver Cancer
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
Liver tumors are hard to treat with radiation because the liver moves every time you breathe. The purpose of this study is to test a new and possibly more accurate way of treating liver tumors. When a...
Eligibility Criteria
Inclusion
- Patient eligible to receive external beam intensity modulated radiotherapy for liver cancer
- Age:21\<80
- KPS \> or = to 80
- Able to tolerate immobilization cradle positioning
- Able to give informed consent
- Histologically confirmed diagnosis of solid tumor malignancy
- Liver metastases visualized on CT imaging (obtained within approximately 6 months from enrollment).
- Target lesion ≤ or = to 8 cm in maximal diameter
- In the case of multiple liver metastases, only one lesion will be targeted per treatment session. Typically the target lesion will be the lesion which is progressing or the cause of symptoms. The target lesion will be picked in consultation with the referring physician.
Exclusion
- Lymphoid primary histology (lymphoma/leukemia)
- Single metastasis in an operable patient. Operable lesions will only be considered for enrollment in the protocol if the patient refuses resection of the metastasis.
- Target lesion \> 8 cm in maximal diameter
- Cirrhosis of the liver (Child's C)
- Liver function enzymes (AST, ALT) \> 3x normal , obtained within 1 month of treatment.
- \< 500 cc uninvolved liver
- Unable to tolerate intravenous CT contrast
- Serum Hemoglobin \< 9.0 (obtained within 1 month of treatment)
- Presence of untreated brain metastases
- Severe pulmonary disease (O2 dependent, unable to walk a flight of stairs)
- Unstable cardiac status
- Unstable angina
- Significant abnormal 12 lead EKG (non sinus arrhythmia or ischemia unsuitable for general anesthesia)
- Congestive Heart Failure
- Abnormal kidney function (serum creatinine \> 1.5) obtained within 1 month of treatment
- Platelet count \<70.000. (obtained within 1 month of treatment).
- INR \> 2.0 (obtained within 1 month of treatment)
- Marker seed placement not possible
- Implanted defibrillator/pacemaker
- Evidence of increased intracranial pressure
- Significant ascites
- Morbid Obesity
- Pregnancy
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00774501
Start Date
October 1 2008
End Date
February 1 2016
Last Update
February 18 2016
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065