Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	no age specified		GITSG-9173

Objectives

I.  Determine whether postoperative adjuvant therapy with 5-fluorouracil and 
supervoltage irradiation can increase the disease-free interval and length of 
survival in patients with curable pancreatic adenocarcinoma of the ductal, 
acinar, and undifferentiated variety.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed acinar, ductal, or undifferentiated pancreatic adenocarcinoma who 
have undergone curative resection of the primary pancreatic neoplasm as well 
as all recognizable regional, nodal, and peritoneal involvement (Whipple 
procedure or total pancreatectomy).  Prior chemotherapy within one year of 
entry excludes, and there may be no prior radiotherapy to the field employed 
in this study.  Patients must have adequate oral nutrition and be able to 
maintain a stable weight for two weeks prior to randomization.  Hematocrit 
less than 30, BUN above 25, bilirubin above 3.0, SGOT above 100, and alkaline 
phosphatase greater than 25% of normal exclude; WBC and platelet counts must 
be at least 4,000 and 150,000/cumm, respectively.  Coexistent malignant 
disease, excluding cutaneous epitheliomas, excludes.  There may be no active 
and significant coexistent disease that would prohibit therapy on this 
protocol.  Per Addendum 1, patients who had a subtotal pancreatectomy due to 
vascular anastomosis are eligible; elevated alkaline phosphatase, SGOT and 
bilirubin levels are no longer contraindications to patient selection.

Expected Enrollment

Approximately 10 patients per year to be entered for a minimum of 150 total 
patients.  Protocol closed August 1984.

Outline

Randomized study.  Patients are randomized 4 to 10 weeks following resection.
Arm I:  Control.  No further therapy.  (Arm closed per Addendum 2, June  1982.)
Arm II:  Radiotherapy plus Single-agent Chemotherapy.  Tumor irradiation using 
supervoltage equipment; plus 5-Fluorouracil, 5-FU, NSC-19893.

Further evidence of effective adjuvant combined radiation and chemotherapy following curative resection of pancreatic cancer. Gastrointestinal Tumor Study Group. Cancer 59 (12): 2006-10, 1987.[PUBMED Abstract]

Kalser MH, Ellenberg SS: Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg 120 (8): 899-903, 1985.[PUBMED Abstract]

Steinberg SM, Kalser MH, Douglass HO, et al.: Experience of patients registered to therapy for adjuvant pancreatic cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 4: C-325, 84, 1985.

Trial Contact Information

Trial Lead Organizations

Gastrointestinal Tumor Study Group

Harold Douglass, MD, FACS, Protocol chair(Contact information may not be current)		Ph: 716-845-5738; 800-685-6825 Email: harold.douglass@roswellpark.org