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

• ClinicalTrials.gov Identifier: NCT01760694
• Recruitment Status: Terminated
• First Posted: January 4, 2013
• Last Update Posted: August 15, 2014
• Sponsor: Southwestern Regional Medical Center
• Information provided by (Responsible Party): Southwestern Regional Medical Center

Study Description

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

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer	Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
• Study Start Date: January 2013
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Efficacy - Progression Free Survival [ Time Frame: 2 years after last patient enrolled ]
   Interim analysis at specific time points. Measure disease response by CT scans per standard of care or when clinically indicated.

Secondary Outcome Measures :

1. Safety [ Time Frame: 2 years after last patient enrolled ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Oklahoma

Southwestern Regional Medical Center, Inc.

Tulsa, Oklahoma, United States, 74133

Sponsors and Collaborators

Southwestern Regional Medical Center

Investigators

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

More Information

Additional Information:

Facility website address 

• Responsible Party: Southwestern Regional Medical Center
• ClinicalTrials.gov Identifier: NCT01760694
• Other Study ID Numbers: SRMC 12-08; IORT Pancreatic ( Other Identifier: Cancer Treatment Centers of America )
• First Posted: January 4, 2013
• Last Update Posted: August 15, 2014
• Last Verified: August 2014

Keywords provided by Southwestern Regional Medical Center:

Pancreatic; Pancreas; Intraoperative Radiation Therapy; Chemotherapy

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Leucovorin; Oxaliplatin; Irinotecan; Folfirinox; Antineoplastic Agents; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antidotes; Protective Agents; Physiological Effects of Drugs; Vitamin B Complex; Vitamins; Micronutrients; Nutrients; Growth Substances