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Patient Eligibility/ID99-289



A Phase I Study of Concomitant Gemzar (Gemcitabine) and Rapid-Fractionation 
External-Beam Radiation Therapy with 3-D Conformal (Intensity Modulated) Treatment
Planning for Patients with Unresectable Adenocarcinoma of the Pancreatic Head
PATIENT ELIGIBILITY

Inclusion:

Patients must have biopsy-proven adenocarcinoma of the pancreas.

Must have locally-advanced disease (tumor extends to the celiac axis or SMA, or occlusion of the SMPV confluence.) with NO evidence of liver or peritoneal metastases.

Must have adequate performance status, blood counts, and liver/kidney function tests. Must be at least 18 years old. Must have adequate oral nutrition w/out nausea/vomiting before radiation.

Must have one functioning kidney out of the prescribed radiation treatment field.

Patients must be able to comply w/ followup visits and receive treatments at the main M D Anderson campus in Houston.

Exclusion:

Patients must not have radiographic evidence of metastatic disease.

Must not have severe neurological disorders that would preclude giving informed consent or following protocol requirements.

Must not have other severe systemic disorders, ie, unconrolled cardiac or pulmonary disease.

Female patients must not be pregnant or breast-feeding.

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Dot.gif (172 bytes) Category C