Clinical trial NCT00774501: The Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy
Official title: A Pilot Study to Assess the Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Keywords: Anesthesia
suspended ventilation
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-10-17
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess safety & feasibility of single dose image-guided intensity modulated radio (IG-IMRT) using gen anesthesia with apneic oxygenation & controlled ventilation to temp suspend respiratory motion for tx of mets liver disease during localization & tx.
timeFrame: conclusion of study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yoshiya Yamada, MD
role: PRINCIPAL_INVESTIGATOR
References: