Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
This study is currently recruiting participants.
Verified January 2013 by Southwestern Regional Medical Center
Sponsor:
Southwestern Regional Medical Center
Information provided by (Responsible Party):
Southwestern Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01760694
First received: December 26, 2012
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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
| Condition | Intervention |
|---|---|
|
Pancreatic Cancer |
Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by Southwestern Regional Medical Center:
Primary Outcome Measures:
- Efficacy - Progression Free Survival [ Time Frame: 2 years after last patient enrolled ] [ Designated as safety issue: Yes ]Interim analysis at specific time points. Measure disease response by CT scans per standard of care or when clinically indicated.
Secondary Outcome Measures:
- Safety [ Time Frame: 2 years after last patient enrolled ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 25 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2019 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy
Other Names:
|
|
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
|
Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760694
Contacts
| Contact: JJ Hale, BS, CCRC | 918-286-5449 | jj.hale@ctca-hope.com |
Locations
| United States, Oklahoma | |
| Southwestern Regional Medical Center, Inc. | Recruiting |
| Tulsa, Oklahoma, United States, 74133 | |
| Contact: JJ Hale, BS, CCRC, CCRP 918-286-5449 jj.hale@ctca-hope.com | |
| Contact: Michele Sumner, BS, CCRC 918-286-5450 michele.sumner@ctca-hope.com | |
| Principal Investigator: Theodore Pollock, DO | |
Sponsors and Collaborators
Southwestern Regional Medical Center
Investigators
| Principal Investigator: | Theodore Pollock, DO | Southwestern Regional Medical Center, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwestern Regional Medical Center |
| ClinicalTrials.gov Identifier: | NCT01760694 History of Changes |
| Other Study ID Numbers: | SRMC 12-08, IORT Pancreatic |
| Study First Received: | December 26, 2012 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Southwestern Regional Medical Center:
|
Pancreatic Pancreas Intraoperative Radiation Therapy Chemotherapy |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 13, 2013