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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Southwestern Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01760694
First received: December 26, 2012
Last updated: August 13, 2014
Last verified: August 2014
  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.


Enrollment: 6
Study Start Date: January 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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:
  • Intraoperative Radiation Therapy (IORT)
  • Chemotherapy: FOLFIRINOX, Oxaliplatin, Irinotecan, 5-FU, Leucovorin
  • Surgery: Resectable or Marginally Resectable
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:
  • Intraoperative Radiation Therapy (IORT)
  • Chemotherapy: FOLFIRINOX, Oxaliplatin, Irinotecan, 5-FU, Leucovorin
  • Surgery: Resectable or Marginally Resectable

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760694

Locations
United States, Oklahoma
Southwestern Regional Medical Center, Inc.
Tulsa, Oklahoma, United States, 74133
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: August 13, 2014
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 September 18, 2014