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:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT00416767
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of neuroendocrine tumor of the duodenum/pancreas by histology or bone scan
* Functional or nonfunctional tumor
* Tumor meets ≥ 1 of the following criteria:
* Hepatic or extrahepatic metastases
* Progressive locally advanced tumor (primary or adenopathies)
* Unresectable disease
* Tumor differentiated and meets the following criteria:
* Ki 67 ≤ 15%
* Less than 10 mitoses per 10 large fields
* Measurable or evaluable disease
* Target lesions must meet 1 of the following criteria within the past 6 months:
* Increase of 20% in the longest diameter
* New metastases detected
* Minimum size of lesions must be 1 of the following:
* More than 15 mm for metastases
* More than 50 mm for primary tumor or local lymph nodes
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Creatinine ≤ 1.5 mg/dL
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.8 mg/dL
* No coronary insufficiency or symptomatic cardiac disease
* No intestinal obstruction, enteropathy, or uncontrolled chronic diarrhea
* No Gilbert's disease
* No psychological, social, familial, or geographic condition that would preclude study treatment
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after completion of study therapy
* No other condition that would preclude study therapy
PRIOR CONCURRENT THERAPY:
* No prior adjuvant radiotherapy
* At least 3 months since prior interferon
* Prior somatostatin analogs or antisecretories allowed
* No other prior treatment for this cancer
* No concurrent radiotherapy to the target lesion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00416767
Study Brief:
Protocol Section:
NCT00416767