In This SectionTexas Health Research & Education Institute
Disease or Condition
ADJUVANT TREATMENT OF RESECTED PANCREATIC CANCER (Pancreatic Cancer)
To compare two chemotherapy drugs, 5-FU and Gemcitabine, as part of treatment for pancreatic cancer before and after chemoradiation.
Histologic proof of adenocarcinoma of the pancreas prior to treatment is required.
Only those patients who have undergone a potentially curative resection (i.e., removal of all gross tumor) are eligible.
Patients will be staged according to the AJCC staging system (Appendix III) with pathologic stage T1-4, N0-1 being eligible; and have a primary tumor of the pancreas (i.e., pancreatic head, neck, uncinate process, body/tail).
The maximum diameter/dimension of the primary tumor, as obtained from the pathologic specimen, is required at registration as well as is the tumor status at the surgical margin (i.e., negative, positive or unknown).
Red cell phenotype for Lewis A and Lewis B antigens must be done.
If positive for either antigen, blood must be drawn for CA19-9 testing within 3 weeks prior to randomization. It may be drawn after randomization but before start of protocol treatment. Frozen samples will be forwarded to LDS Hospital per Section 10.3.
Protocol treatment must begin within 3-8 weeks (21-56 days) after definitive tumor-related surgery and within 5 business days after randomization.
Age > 18.
Karnofsky performance status > 60.
Before starting therapy the patient should be able to maintain adequate oral nutrition (e.g., = 1500 calories estimated caloric intake per day) and be free of significant nausea and vomiting. If necessary, a feeding tube should be used to maintain caloric intake above 1500 calories daily.
Signed study-specific informed consent form that includes a section on the possibility of the need for deep line access (PICC, Groshong, Hickman or Port).
Patients must have adequate bone marrow function with WBC count of > 3000 and platelet count > 100,000.
Patients must have serum bilirubin and creatinine levels < 1.5 x the institutional upper limit of normal.
SGOT must be less < 5 x the institutional upper limit of normal.
Non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas are not eligible.
Patients with M1 or NX staging are unacceptable; patients in whom regional lymph nodes cannot be identified for pathologic review are ineligible (See Appendix III).
Pregnant women may not participate.
Women or men of reproductive potential may not participate unless they agree to use an effective contraceptive method.
Patients with recurrent disease are ineligible.
Prior radiation therapy to any site or chemotherapy.
Patients with a previous history of active malignancy within 5 years prior to study entry, except
1) in situ cervical carcinoma or
2) non-melanoma skin cancer. Karnofsky performance status < 60.