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

NCT ID: NCT01760694

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-07-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Multi-Modality; IORT, Surgery, Radiation, Chemotherapy

Intervention Type: OTHER

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

Group Type: EXPERIMENTAL

Multi-Modality; IORT, Surgery, Radiation, Chemotherapy

Intervention Type: OTHER

Interventions

Multi-Modality; IORT, Surgery, Radiation, Chemotherapy

Intervention Type: OTHER

Other Intervention Names

Intraoperative Radiation Therapy (IORT); Chemotherapy: FOLFIRINOX, Oxaliplatin, Irinotecan, 5-FU, Leucovorin; Surgery: Resectable or Marginally Resectable

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwestern Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore Pollock, DO

Role: PRINCIPAL_INVESTIGATOR

Southwestern Regional Medical Center, Inc.

Locations

Southwestern Regional Medical Center, Inc.

Tulsa, Oklahoma, United States

Countries

United States

Other Identifiers

IORT Pancreatic

Identifier Type: OTHER

Identifier Source: secondary_id

SRMC 12-08

Identifier Type: -

Identifier Source: org_study_id