Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resectable Patients<br>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 | Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy<br> <br> * Other names: Surgery: Resectable or Marginally Resectable;|
| Experimental: Marginally Resectable Patients<br>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 | Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy<br> <br> * Other names: Surgery: Resectable or Marginally Resectable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Progression Free Survival | Interim analysis at specific time points. Measure disease response by CT scans per standard of care or when clinically indicated. | 2 years after last patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years after last patient enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic, Pancreas, Intraoperative Radiation Therapy, Chemotherapy