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

NCT02626520 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-11-13

Study results available
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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.

Conditions

  • Ductal Adenocarcinoma of Pancreas
  • Adenocarcinoma of Ampulla

Interventions

DRUG

Gemcitabine and nanoparticle albumin bound paclitaxel

Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles

DRUG

5-fluorouracil and irinotecan

FOLFIRI.3 given every 14 days x 4 cycles

RADIATION

Preoperative chemoradiation

Pre-operative chemoradiation to 40 Gy in 20 fractions

PROCEDURE

Definitive resection

Definitive surgical resection of primary tumor

Sponsors & Collaborators

  • Essentia Health

    lead OTHER

Principal Investigators

  • Peter Kebbekus, MD, PhD · Essentia Health Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-11
Primary Completion
2016-09-20
Completion
2017-09-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02626520 on ClinicalTrials.gov