Back to resultsMulti-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-Modality; IORT, Surgery, Radiation, Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic, Pancreas, Intraoperative Radiation Therapy, Chemotherapy
Eligibility 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
Sites / Locations
- Southwestern Regional Medical Center, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Resectable Patients
Marginally Resectable Patients
Arm Description
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
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
Outcomes
Primary Outcome Measures
Efficacy - Progression Free Survival
Interim analysis at specific time points. Measure disease response by CT scans per standard of care or when clinically indicated.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01760694
First Posted
December 26, 2012
Last Updated
August 13, 2014
Sponsor
Southwestern Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01760694
Brief Title
Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
Official Title
Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southwestern Regional Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic, Pancreas, Intraoperative Radiation Therapy, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resectable Patients
Arm Type
Experimental
Arm Description
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
Arm Title
Marginally Resectable Patients
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Multi-Modality; IORT, Surgery, Radiation, Chemotherapy
Other Intervention Name(s)
Intraoperative Radiation Therapy (IORT), Chemotherapy: FOLFIRINOX, Oxaliplatin, Irinotecan, 5-FU, Leucovorin, Surgery: Resectable or Marginally Resectable
Primary Outcome Measure Information:
Title
Efficacy - Progression Free Survival
Description
Interim analysis at specific time points. Measure disease response by CT scans per standard of care or when clinically indicated.
Time Frame
2 years after last patient enrolled
Secondary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
2 years after last patient enrolled
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Pollock, DO
Organizational Affiliation
Southwestern Regional Medical Center, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwestern Regional Medical Center, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
12. IPD Sharing Statement
Links:
URL
http://cancercenter.com
Description
Facility website address
Learn more about this trial
Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
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