Study Stopped
Lack of enrollment
Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
2 other identifiers
interventional
6
1 country
1
Brief Summary
To assess the ability of a combination of updated and approved modalities in the treatment of first line pancreatic cancer patients to increase the time to Progression Free Survival
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pancreatic-cancer
Started Jan 2013
Shorter than P25 for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedFirst Posted
Study publicly available on registry
January 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 15, 2014
August 1, 2014
1.5 years
December 26, 2012
August 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy - Progression Free Survival
Interim analysis at specific time points. Measure disease response by CT scans per standard of care or when clinically indicated.
2 years after last patient enrolled
Secondary Outcomes (1)
Safety
2 years after last patient enrolled
Study Arms (2)
Resectable Patients
EXPERIMENTALSurgery with Intraoperative Radiation Therapy (IORT). Radiation Therapy within 6-8 weeks after surgery followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery
Marginally Resectable Patients
EXPERIMENTAL2-3 cycles of neoadjuvant FOLFIRINOX then restaged, then undergo surgery with Intraoperative Radiation Therapy (IORT) within 2-4 weeks following chemotherapy. Then Radiation Therapy within 6-8 weeks followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery for a total of 2-4 cycles
Interventions
Eligibility Criteria
You may qualify if:
- Histologically proven Exocrine Adenocarcinoma of the pancreas
- Clinically resectable or marginally resectable disease
- No prior radiation or chemotherapy for carcinoma of the pancreas
- ECOG performance status of 0-1
- Patients must be medically able to undergo surgical resection
- Patients of child bearing potential must follow study specific precautions
- Women that are lactating will not be excluded on the condition that they dispose their breast milk.
- Adequate hematologic and biochemical parameters.
You may not qualify if:
- Prior treatment for pancreatic cancer.
- Concurrent investigational treatments.
- Unresectable pancreatic mass.
- Neuroendocrine Histological pancreatic cancer
- Distant Metastatic disease
- Any condition that, in the option of the investigator, would compromise the well being of the patient or anything that would prevent the patient from meeting or performing study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southwestern Regional Medical Center, Inc.
Tulsa, Oklahoma, 74133, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Theodore Pollock, DO
Southwestern Regional Medical Center, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2012
First Posted
January 4, 2013
Study Start
January 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 15, 2014
Record last verified: 2014-08