A Phase II Trial of Escalated Dose Proton Radiotherapy With Elective Nodal Irradiation and Concomitant Chemotherapy for Patients With Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma
The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having borderline resectable disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).
• Biopsy proven unresectable adenocarcinoma of the pancreas.
• Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
• A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
• Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
• Required pretreatment laboratory parameters:
‣ Absolute granulocyte count (AGC/ANC) ≥ 1.8 thou/mm3
⁃ Platelet count ≥ 100,000/mm3
⁃ Bilirubin \< 2 mg/dl
⁃ ALT/SGPT \< 3x upper limit of normal
⁃ Creatinine \< 3 mg/dl