The Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy



Status:Completed
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - 80
Updated:4/21/2016
Start Date:October 2008
End Date:February 2016

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A Pilot Study to Assess the Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy

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 person is asleep under anesthesia, it is safe to stop
breathing motion for a while. The liver will stop moving and radiation can be given to a
liver tumor. The study is being done to see if radiation can be given to liver tumors safely
and accurately in this way.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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from
New York, NY
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