Pancreatic Cancer
Conditions
Keywords
Pancreatic, Pancreas, Intraoperative Radiation Therapy, Chemotherapy
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.
Interventions
OTHERMulti-Modality; IORT, Surgery, Radiation, Chemotherapy
Sponsors
Southwestern Regional Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Progression Free Survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety | 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. |
Countries
United States
Outcome results
None listed