Multi-Modality Therapy For Untreated Patients With Resectable Or Marginally Resectable Pancreatic Cancer

Study Overview

Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer

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

For resectable patient; surgery 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. For marginally resectable patients; the patients will have 2-3 cycles of neoadjuvant chemotherapy of FOLFIRINOX and then restaged, undergo surgery with IORT within 2-4 weeks following chemotherapy. Then radiation therapy starting within 6-8 weeks. Followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery for a total of 2-4 cycles.

Pancreatic Cancer

OTHER: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy

SRMC 12-08
IORT Pancreatic (OTHER Identifier) (OTHER: Cancer Treatment Centers of America)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-12-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-08-13
First Submitted that Met QC Criteria 2013-01-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-08-15
First Posted (ESTIMATED) 2013-01-04	Results First Posted N/A	Last Verified 2014-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Resectable Patients Surgery 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	OTHER: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy
EXPERIMENTAL: Marginally Resectable Patients 2-3 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	OTHER: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Resectable Patients

Surgery 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

OTHER: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy

EXPERIMENTAL: Marginally Resectable Patients

2-3 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

OTHER: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Safety	Interim analysis at certain time points. Measure disease response by CT scans per standard of care or when clinically indicated. Collect adverse events and serious adverse events. Collect quality of life data.	2 years after last patient enrolled

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Theodore Pollock, DO, Southwestern Regional Medical Center, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record