Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT00466856
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Pathologically confirmed neuroendocrine tumor metastatic to the liver
* Well-differentiated or moderately well-differentiated neuroendocrine tumors
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral CT scan
* Symptomatic disease, meeting one of the following criteria:
* Refractory carcinoid symptoms, defined as Carcinoid Symptom Severity scale \> 2 despite use of octreotide acetate at ≥ 200 mcg subcutaneously three times daily (or 20 mg intramuscularly once monthly) for ≥ 4 weeks
* Evidence of radiographic progression with either of the following manifestations:
* Moderate-severe right upper quadrant pain and unintentional weight loss \> 10%
* Decline in Karnofsky performance status \> 10 points
* At least a 20% increase in the sum of the longest diameters of target lesions in the liver within the past 12 months
* No more than 75% replacement of normal liver by neuroendocrine tumor
* No more than 20% arteriovenous lung shunting on a technetium Tc 99m macro-aggregated albumin nuclear scan
* No equivocal, nonmeasurable, or nonevaluable liver metastasis
PATIENT CHARACTERISTICS:
* Karnofsky performance status 50-100%
* Life expectancy ≥ 6 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Creatinine ≤ 1.5 mg/dL
* Bilirubin ≤ 2.0 mg/dL
* Albumin ≥ 3.0 g/dL
* Absolute granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 65,000/mm³
* Hemoglobin \> 9.0 g/dL
* INR ≤ 1.4
* No hepatic arterial anatomy that would preclude the administration of study treatment into the liver
* No nonmalignant disease that would preclude study participation
* No other malignancy within the past 5 years except for cured basal cell carcinoma of the skin or cured carcinoma in situ of the uterine cervix
PRIOR CONCURRENT THERAPY:
* Prior surgery, chemotherapy, or locally ablative technique for the liver cancer allowed
* No prior radiotherapy to the upper abdomen that includes the liver in the treatment field
* No investigational drug or agent/procedure (i.e., participation in another clinical trial) within the past 4 weeks
* No other specific anticancer treatment (other than octreotide acetate) during and for 3 months after completion of study therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00466856
Study Brief:
Protocol Section:
NCT00466856