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
Verified date | October 2018 |
Source | Essentia Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 11 |
Est. completion date | September 14, 2017 |
Est. primary completion date | September 20, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Essentia Health Cancer Center | Duluth | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Essentia Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relapse Free Survival | Percentage of patients alive and free of detectable disease 1 yr from start of treatment | 1 yr form onset of treatment | |
Secondary | R-0 Rate | Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection) | Time of surgery | |
Secondary | Overall Survival | Time to death from any cause measured from start of treatment | Up to 3 years from registration |