| Inclusion Criteria: | 1) Biopsy proven completely resected (R0 or R1) pancreatic adenocarcinoma of the pancreatic head or uncinate process (AJCC Stage I-III). Surgery (pancreaticoduodenectomy) may be performed at M. D. Anderson Cancer Center or prior to referral to M. D. Anderson Cancer Center. Protocol treatment must begin within 12 weeks of surgery.
2) Postoperative (pre-treatment) CT scan without evidence of radiographically defineable residual primary/metastatic disease or clinically significant post-surgical changes.
3) Staging studies completed within three weeks +/- 3 days of protocol registration.
4) Hb >9.0 g/%, WBC >3,000 cells/mm3 (ANC >1,500 cells/mm3), platelets >75,000 cells/mm3.
5) Postoperative serum CA 19-9 < 100.
6) Performance status: Zubrod 0 or 1.
7) Creatinine £1.5 mg/dL and calculated or measured creatinine clearance (CrCl) of 60 ml/min or greater by the following formula: CrCl = (140 – age) x Wt (kg) x 0.85 (female) OR x 1.00 (male) 72 x serum creatinine
8) Patients should have bilateral renal function, as determined on excretory urogram (IVP) or abdominal CT, or ³ 2/3 of one functioning kidney must be able to be shielded from the radiation beam.
9) No acute infections at the time of therapy initiation.
10) Women of childbearing potential must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent.
11) Patients must sign a study-specific consent form, which is attached to this protocol.
12) Patients with a prior history of non-pancreatic malignancy who are free of disease from their primary cancer may be eligible at the discretion of the study chair. |