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

Not Applicable

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy

• Registration Number: NCT01760694
• Lead Sponsor: Southwestern Regional Medical Center

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

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 Timeline

• Study First Submitted: 2012-12-26
• Study Start: 2013-01
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resectable Patients	Multi-Modality; IORT, Surgery, Radiation, Chemotherapy	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
Marginally Resectable Patients	Multi-Modality; IORT, Surgery, Radiation, Chemotherapy	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

Primary Outcome Measures

Name	Time	Method
Efficacy - Progression Free Survival	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

Name	Time	Method
Safety	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.

Trial Locations

Locations (1)

Southwestern Regional Medical Center, Inc.; 🇺🇸 Tulsa, Oklahoma, United States