Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis
- Determine whether neoadjuvant chemoradiotherapy comprising gemcitabine hydrochloride,
cisplatin, and radiotherapy is better than immediate surgery, in terms of median
survival, in patients with locally resectable adenocarcinoma of the pancreatic head.
- Compare 3-year survival rate in patients treated with these regimens.
- Compare R0 resection rate in these patients.
- Compare the rate of medium and high toxicity events in these patients.
- Compare the rate of complete and incomplete remission of the tumor as measured by
radiographic imaging studies.
- Compare the rate of different regression gradings in resected tumor specimens.
- Compare the quality of life of these patients.
OUTLINE: This is a prospective, randomized, controlled, open-label, multicenter study.
Patients are stratified according to participating center and staging laparoscopy (yes vs
no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV
over 1 hour on days 1, 8, 22, and 29. Patients also undergo radiotherapy to the tumor
and surrounding lymph nodes 5 days a week for 5 weeks followed by 3 more doses of
radiotherapy directly to the tumor. Approximately 6 weeks after finishing
chemoradiotherapy, patients with no evidence of disease progression undergo surgery to
remove the tumor.
- Arm II: Patients undergo surgery to remove the tumor. After surgery, all patients
receive adjuvant chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes
on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at the end of chemotherapy and before surgery (arm
I), and then at 6 weeks, 6 months, 12 months, and 24 months after surgery.
After completion of study treatment, patients are followed every 3 months for 2 years and
then at 3 years.
PROJECTED ACCRUAL: A total of 254 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
W. Hohenberger, MD