Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
Status: | Recruiting |
---|---|
Conditions: | Cancer, Cancer, Pancreatic Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/5/2014 |
Start Date: | January 2013 |
End Date: | January 2019 |
Contact: | JJ Hale, BS, CCRC |
Email: | jj.hale@ctca-hope.com |
Phone: | 918-286-5449 |
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
of first line pancreatic cancer patients to increase the time to Progression Free Survival
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.
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
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