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

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

Study Description
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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
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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

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760694


Locations
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United States, Oklahoma
Southwestern Regional Medical Center, Inc.
Tulsa, Oklahoma, United States, 74133
Sponsors and Collaborators
Southwestern Regional Medical Center
Investigators
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Principal Investigator: Theodore Pollock, DO Southwestern Regional Medical Center, Inc.
More Information
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Additional Information:
Facility website address  This link exits the ClinicalTrials.gov site

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Responsible Party: Southwestern Regional Medical Center
ClinicalTrials.gov Identifier: NCT01760694     History of Changes
Other Study ID Numbers: SRMC 12-08
IORT Pancreatic ( Other Identifier: Cancer Treatment Centers of America )
First Posted: January 4, 2013    Key Record Dates
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:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
 Oxaliplatin
Irinotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action