Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT01760694 |
Recruitment Status :
Terminated
(Lack of enrollment)
First Posted : January 4, 2013
Last Update Posted : August 15, 2014
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Condition or disease | Intervention/treatment | Phase |
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Pancreatic Cancer | Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
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Experimental: Resectable Patients
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
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Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy
Other Names:
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Experimental: Marginally Resectable Patients
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
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Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy
Other Names:
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- Efficacy - Progression Free Survival [ Time Frame: 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.
- Safety [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760694
United States, Oklahoma | |
Southwestern Regional Medical Center, Inc. | |
Tulsa, Oklahoma, United States, 74133 |
Principal Investigator: | Theodore Pollock, DO | Southwestern Regional Medical Center, Inc. |
Responsible Party: | Southwestern Regional Medical Center |
ClinicalTrials.gov Identifier: | NCT01760694 |
Other Study ID Numbers: |
SRMC 12-08 IORT Pancreatic ( Other Identifier: Cancer Treatment Centers of America ) |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | August 15, 2014 |
Last Verified: | August 2014 |
Pancreatic Pancreas Intraoperative Radiation Therapy Chemotherapy |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Leucovorin Oxaliplatin Irinotecan Folfirinox Antineoplastic Agents |
Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antidotes Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances |