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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01760694
• Other study ID #: SRMC 12-08
• Secondary ID: IORT Pancreatic
• Status: Terminated
• Phase: N/A
• First received: December 26, 2012
• Last updated: August 13, 2014
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Southwestern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Southwestern Regional Medical Center, Inc.	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Southwestern Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - Progression Free Survival	Interim analysis at specific time points. Measure disease response by CT scans per standard of care or when clinically indicated.	2 years after last patient enrolled	Yes
Secondary	Safety	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.	2 years after last patient enrolled	Yes

External Links

•   Facility website address