A Phase II Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of the pancreas or a serum CA19-9 level
higher than normal limits and an pancreas cancer-compatible radiological features in
one or more in CT/MRI/PET scans
- Unresectable disease base on institutional standard criteria of unresectability or
recurrent disease following radical surgery. There is no evidence of metastatic
disease in the major viscera and no peritoneal seeding
- Patients with biliary or gastroduodenal obstruction must have drainage prior to
starting chemoradiation
- All malignant disease must be encompassable within a single irradiation field
(15x15cm maximum)
- All patients must have radiographically assessable disease
- No previous irradiation to the planned field
- Age of ≥ 18 years
- Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
- Required Entry Labortory Parameters:
- WBC count ≥ 2,000/mm3
- hemoglobin level ≥ 7.5 g/dL
- platelet count ≥ 100,000/mm3
- total bilirubin ≤ 2.0 mg/dL (Patients with elevated bilirubin due to obstruction
should be stented and their bilirubin should be decreased ≤ 2.0 mg/dL prior to
study entry)
- creatinine ≤ 3.0 mg/dL
- Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.
Exclusion Criteria:
- There is evidence of metastasis in the major viscera or peritoneal seeding.
- Age of < 18 years
- Previous history of RT adjacent to planned field
- Poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG)
score
- Pregnant or breast feeding status
- Previous history uncontrolled other malignancies within 2 years