RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may
make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation
therapy after surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation
therapy in treating patients who have undergone surgery to remove cancer of the pancreas.
- Determine the time to disease progression, local control, and survival of patients with
previously resected pancreatic cancer treated with adjuvant gemcitabine and
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29,
and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the
absence of disease progression or unacceptable toxicity.
Beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and
with less than 10% weight loss during study receive additional gemcitabine IV over 30
minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.
Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 or 3.4
- Histologically confirmed invasive adenocarcinoma of the pancreas
- Prior gross total resection via a pancreaticoduodenectomy (Whipple resection or
total pancreatectomy) within the past 2 months
- No clinical evidence of gross residual disease at time of surgery
- No focally positive margins (tumor at the margin)
- No unresected nodal disease or metastatic disease to the liver, peritoneal surfaces,
- Over 18
- ECOG 0-2
- More than 6 months
- Granulocyte count greater than 1,500/mm3
- Hemoglobin greater than 10 g/dL
- Platelet count greater than 100,000/mm3
- Bilirubin less than 2.0 mg/dL
- Creatinine less than 2.0 mg/dL
- Able to maintain adequate oral nutrition
- Documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior
- No other malignancy within the past 2 years except inactive nonmelanoma skin cancer
or carcinoma in situ of the cervix or breast
- Non-metastatic prostate cancer allowed if more than 2 year survival likely
- No other serious medical or psychiatric illness that would preclude study or limit
survival to less than 2 years
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No concurrent routine growth factors
- No prior chemotherapy for pancreatic cancer
- Not specified
- No prior abdominal radiotherapy for pancreatic cancer
- See Disease Characteristics