TerminatedPhase 2

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

Stopped: Study team felt toxicity of study regimen outweighed potential benefit.

United States11 participantsStarted 2016-05-11

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Relapse Free Survival

Timeframe: 1 yr form onset of treatment

Trial details

NCT IDNCT02626520

SponsorEssentia Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09-20

Results submitted2018-07-13

View on ClinicalTrials.gov More Ductal Adenocarcinoma of Pancreas trials