Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Patients who have confirmed cancer arising from the pancreas
Eligibility Criteria
Inclusion Criteria:
- Is the patient 18 years of age or older.
- Does the patient have histologically or cytologically proven carcinoma of the pancreas
- Is the tumor unresectable or medically inoperable
- Does the patient have a Zubrod performance status of ≤ 2 (appendix I).
- Does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥ 100,000/mm3
- Does the patient have adequate renal function (creatinine < 2 mg/dl) and hepatic function (bilirubin < 3 mg/dl), with relief of biliary obstruction if present
- Is the patient free of significant co-morbid conditions that would preclude safe administration or completion of protocol therapy
- If the patient is of reproductive potential, has he or she agreed to use an effective method of contraception during treatment on this trial and for 6 months after treatment
- Is the patient aware of the investigational nature of the therapy such that they can provide written informed consent
Exclusion Criteria:
- Does the patient have a neuroendocrine tumor of the pancreas
- Does the patient have metastatic disease
- Does the patient have a history of abdominal radiation therapy
- Is there history of more than 1 month of therapy with single agent gemcitabine
- Has the patient used any investigational agent in the month before enrollment into the study
Sites / Locations
- Rush University Medical Center
- University Of Michigan
Arms of the Study
Arm 1
Experimental
Radiation Dose Escalation with Gemcitabine
INTENSITY MODULATED RADIOTHERAPY Radiation dose escalation: Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4 BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level Gemcitabine: 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment