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A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas


Chemotherapy:Capecitabine on radiation days

Proton radiation over 7 weeks

Consolidation Chemotherapy:Gemcitabine


Inclusion Criteria:



Pathologically confirmed adenocarcinoma of the pancreas.

Patients must be medically inoperable or have unresectable disease

Exclusion Criteria:

- Evidence of distant metastasis; evidence of metastatic disease in the major viscera
(organs), peritoneal seeding and/or ascites.

- Previous irradiation to the abdomen that would compromise the ability to deliver the
prescribed treatment.

- Prior surgical resection.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cumulative incidence of grade3+ bowel perforation, grade 3+ bleeding and grade4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)

Outcome Time Frame:

1 year following the completion of radiation therapy

Safety Issue:

Yes

Principal Investigator

R. Charles Nichols, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 0609-PC01

NCT ID:

NCT00685763

Start Date:

March 2008

Completion Date:

July 2038

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic cancer
  • Unresectable
  • Proton radiation
  • Chemotherapy
  • Pancreatic Neoplasms

Name

Location

University of Florida Proton Therapy InstituteJacksonville, Florida  32206