Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla

• Status: Terminated
• Trial end date: 2017-09-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Essentia Health
• Treatments: Albumin-Bound Paclitaxel; Fluorouracil; Gemcitabine; Irinotecan; Paclitaxel; Pancrelipase

Criteria

Inclusion Criteria:

• Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional imaging.

• Fitness for chemotherapy in judgement of treating physician

• Bilirubin < 4 (any means of biliary drainage acceptable)

Exclusion Criteria:

• Medical or mental illness precluding provision of informed consent

• Pregnancy

• Active infection for which neutropenia would pose high risk of mortality