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A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas


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

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Trial Information

A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas


Chemotherapy capecitabine on radiation days

Proton radiation over 6 weeks

Surgery 6 weeks after radiation completion

Adjuvant Chemotherapy starting 2-8 weeks after surgery with Gemzar


Inclusion Criteria:



- Pathologically confirmed adenocarcinoma of the pancreas.

- Patients must have marginally resectable disease.

- Patients with biliary obstruction must have adequate drainage prior to starting
chemoradiation.

Exclusion Criteria:

- Evidence of distant metastasis including peritoneal seeding and/or ascites.

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

- Prior surgical resection.

- Gastroduodenal obstruction

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ 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

Romaine C Nichols, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 0704-PC02

NCT ID:

NCT00763516

Start Date:

February 2009

Completion Date:

September 2040

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Proton radiation
  • Chemotherapy
  • Xeloda
  • Gemzar
  • Resectable
  • Surgery
  • Carcinoma
  • Pancreatic Neoplasms

Name

Location
University of Florida Proton Therapy Institute Jacksonville, Florida  32206