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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

Tracking Information
First Submitted Date  ICMJE December 26, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date August 15, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01760694 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
Official Title  ICMJE Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy
  • 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
    Intervention: Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 13, 2014)
6
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2013)
25
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760694
Other Study ID Numbers  ICMJE SRMC 12-08
IORT Pancreatic ( Other Identifier: Cancer Treatment Centers of America )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southwestern Regional Medical Center
Study Sponsor  ICMJE Southwestern Regional Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Theodore Pollock, DO Southwestern Regional Medical Center, Inc.
PRS Account Southwestern Regional Medical Center
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP