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

Southwestern Regional Medical Center6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Multi-Modality; IORT, Surgery, Radiation, ChemotherapyOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

Southwestern Regional Medical Center, Inc.

Tulsa, Oklahoma, United States

Outcomes

Primary Outcomes

Efficacy - Progression Free Survival

Interim analysis at specific time points. Measure disease response by CT scans per standard of care or when clinically indicated.

Time frame: 2 years after last patient enrolled

Secondary Outcomes

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.

Time frame: 2 years after last patient enrolled

Data from ClinicalTrials.gov

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