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

Study Overview

• Status: Terminated
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy

Detailed Description

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
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Southwestern Regional Medical Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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; Other Names: Intraoperative Radiation Therapy (IORT); Chemotherapy: FOLFIRINOX, Oxaliplatin, Irinotecan, 5-FU, Leucovorin; Surgery: Resectable or Marginally Resectable
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 weeks of surgery for a total of 2-4 cycles	Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy; Other Names: Intraoperative Radiation Therapy (IORT); Chemotherapy: FOLFIRINOX, Oxaliplatin, Irinotecan, 5-FU, Leucovorin; Surgery: Resectable or Marginally Resectable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Southwestern Regional Medical Center
• Investigators: Principal Investigator: Theodore Pollock, DO, Southwestern Regional Medical Center, Inc.

Publications and helpful links

Helpful Links

• Facility website address

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 26, 2012
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 13, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Pancreas; Chemotherapy; Pancreatic; Intraoperative Radiation Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protective Agents; Topoisomerase Inhibitors; Micronutrients; Vitamins; Topoisomerase I Inhibitors; Antidotes; Vitamin B Complex; Oxaliplatin; Leucovorin; Irinotecan; Folfirinox
• Other Study ID Numbers: SRMC 12-08; IORT Pancreatic (Other Identifier: Cancer Treatment Centers of America)