Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy - Progression Free Survival
Outcome Description:
Interim analysis at specific time points. Measure disease response by CT scans per standard of care or when clinically indicated.
Outcome Time Frame:
2 years after last patient enrolled
Safety Issue:
Yes
Principal Investigator
Theodore Pollock, DO
Investigator Role:
Principal Investigator
Investigator Affiliation:
Southwestern Regional Medical Center, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
SRMC 12-08
NCT ID:
NCT01760694
Start Date:
January 2013
Completion Date:
January 2019
Related Keywords:
- Pancreatic Cancer
- Pancreatic
- Pancreas
- Intraoperative Radiation Therapy
- Chemotherapy
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Southwestern Regional Medical Center, Inc. | Tulsa, Oklahoma 74133 |
