Adenocarcinoma of Ampulla Clinical Trial
Official title:
Phase 2 Evaluation of a Community-Based Multi-modality Management Algorithm for Clinically Non-metastatic Ductal Adenocarcinoma of the Exocrine Pancreas or Ampulla
Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.
Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior
therapy and have no clinically detectable metastatic disease will be enrolled. Management
will be driven by resectability status as defined by the American College of Surgeons. All
patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced
(Unresectable).
All patients will be treated initially with gemcitabine and nanoparticle albumin bound
paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable,
who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other
patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan
(FOLFIRI-3) every 14 days x 4 cycles.
All patients without progression will then receive chemoradiation consisting of external beam
radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will
receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week,
Mitomycin-C at 3 mg.m2 on d1, 8, 15 & 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and
unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.
After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or
Borderline Resectable disease will undergo definitive surgery.
Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients
post-operatively.
Patients will then be actively followed every 3 to 6 months in keeping with National
Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence,
late toxicity and vital status every 6 months through 5 years.
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