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

Southwestern Regional Medical Center

Status: Terminated

Conditions: Pancreatic Cancer

Treatments: Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01760694

SRMC 12-08

IORT Pancreatic (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Resectable Patients

Experimental group

Description:

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

Treatment:

Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy

Marginally Resectable Patients

Experimental group

Description:

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

Treatment:

Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy