RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with intensity-modulated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with intensity-modulated radiation therapy and surgery works in treating patients with localized pancreatic cancer that can be removed by surgery.
Primary Outcome Measures:
- Median overall survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 1- and 2-year survival rate [ Designated as safety issue: No ]
- Median recurrence-free survival following pancreaticoduodenectomy [ Designated as safety issue: No ]
- Clinical response rate to induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
- Pathologic response rate to induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
- Biochemical response rate (CA 19-9 tumor marker) to induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
- Surgical completion rate and complication rate following induction chemotherapy and neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: |
30 |
| Study Start Date: |
January 2008 |
| Estimated Primary Completion Date: |
December 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To assess the median overall survival of patients with resectable, localized adenocarcinoma of the pancreas treated with induction chemotherapy comprising gemcitabine hydrochloride, docetaxel, and capecitabine and neoadjuvant chemoradiotherapy comprising capecitabine, oxaliplatin, and intensity-modulated radiotherapy followed by surgical resection and adjuvant chemotherapy comprising gemcitabine hydrochloride and oxaliplatin.
Secondary
- To determine the 1- and 2-year survival rate in patients treated with this regimen.
- To determine the median recurrence-free survival following pancreaticoduodenectomy.
- To determine the clinical response rate to induction chemotherapy and neoadjuvant chemoradiotherapy.
- To determine the pathologic response rate to induction chemotherapy and neoadjuvant chemoradiotherapy.
- To determine the CA 19-9 tumor marker response rate to induction chemotherapy and neoadjuvant chemoradiotherapy.
- To determine the surgical completion rate and complication rate following induction chemotherapy and neoadjuvant chemoradiotherapy.
- To determine the frequency and severity of toxicities associated with this regimen.
OUTLINE: This is a multicenter study.
- Induction chemotherapy: Patients receive gemcitabine hydrochloride IV over 75 minutes and docetaxel IV over 30 minutes on days 4 and 11. Patients also receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
- Neoadjuvant chemoradiotherapy: Beginning no more than 14 days after completion of induction chemotherapy, patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Patients also undergo intensity-modulated radiotherapy daily on days 1-5 and 8-12 (total of 10 fractions).
- Surgical resection: Approximately 2-6 weeks after completion of neoadjuvant chemoradiotherapy, patients undergo pancreaticoduodenectomy or "Whipple" procedure with or without preservation of the pylorus and proximal duodenum or a distal pancreatectomy with or without splenectomy.
- Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive gemcitabine hydrochloride alone IV over 100 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.