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 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT00544193
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of any of the following upper gastrointestinal malignancies:
* Localized pancreatic adenocarcinoma
* Stage I, II, or III disease
* Parapancreatic node involvement and locally recurrent disease allowed
* Locally advanced biliary, gallbladder, or ampullary adenocarcinoma
* Stage II, III, or locally recurrent disease
* Histologically confirmed locally advanced gastric adenocarcinoma
* T3, T4, or node positive OR locally recurrent disease
* Histologically confirmed locally advanced duodenal cancer
* Stage II or III disease
* Locally advanced, but unresectable cancers may be included on protocol if appropriate for intraoperative radiotherapy (IORT)
* Other histologies may be considered for this protocol except for lymphoma, sarcoma, or neuroendocrine tumors
* Patients with evidence of metastatic disease are eligible if there is significant local disease warranting surgery and IORT
PATIENT CHARACTERISTICS:
* Karnofsky performance status \> 60%
* Life expectancy \> 4 months
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Serum creatinine \< 2.0 mg/dL
* ALT \< 3 x normal
* Bilirubin \< 2 x normal
* Must be able to give voluntary informed consent
* No severe intercurrent illness that would make the patient inappropriate for laparotomy or otherwise inappropriate for treatment on protocol
* Prior history of malignancy allowed
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C)
* Prior gemcitabine hydrochloride allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00544193
Study Brief:
Protocol Section:
NCT00544193