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Proton Radiation for Resectable Carcinoma of the Pancreas (PC02)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Florida
Information provided by (Responsible Party):
University of Florida Identifier:
First received: September 30, 2008
Last updated: September 22, 2014
Last verified: September 2014

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will look at the side effects from the treatment and the quality of your life in relation to pain. It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.

Condition Intervention Phase
Pancreatic Cancer
Radiation: Proton radiation and chemotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas

Resource links provided by NLM:

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start) [ Time Frame: 1 year following the completion of radiation therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collect and analyze tumor control outcomes [ Time Frame: 1 year following the completion of radiation therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: February 2009
Estimated Study Completion Date: September 2040
Estimated Primary Completion Date: September 2039 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton radiation and chemotherapy

Proton radiation

Capecitabine chemotherapy on radiation days


Gemcitabine chemotherapy

Radiation: Proton radiation and chemotherapy

Neoadjuvant Chemotherapy Capecitabine (Xeloda®) 1,000 mg by mouth twice a day 5 days/week (M-F) on radiation days only

Proton radiation 50.4 cobalt gray equivalent(CGE) in 28 fractions over 6 weeks

Surgery: Gross total resection of primary tumor and regional lymph nodes done 6 weeks after completion of radiation

Adjuvant Chemotherapy starting 2-8 weeks after surgery Suggested Regimen: Gemcitabine (Gemzar®) 1,000 mg/m2 IV total of 18 doses

Other Names:
  • Xeloda
  • Gemzar

Detailed Description:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00763516

Contact: Intake Coordinator 877-686-6009

United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Romaine C Nichols, MD         
Sponsors and Collaborators
University of Florida
Principal Investigator: Romaine C Nichols, MD University of Florida Proton Therapy Institute
  More Information

Additional Information:
Sugahara S et al. Clinical results of proton beam therapy for cancer of the esophagus. Int. J. Radiation Oncology Biol. Phys. 2005; 61(1): 76-84.
Bush D et al. Proton beam radiotherapy of hepatocellular carcinoma: Preliminary results of a phase II trial. Gastroenterology 2004; 127: S189-S193. 23. Gierga D et al. Quantification of respiration-induced abdominal tumor motion and its impact on IMRT dose distributions. Int. J. Radiation Oncology Biol. Phys. 2004; 58(5): 1584-1595.

Responsible Party: University of Florida Identifier: NCT00763516     History of Changes
Other Study ID Numbers: UFPTI 0704-PC02
Study First Received: September 30, 2008
Last Updated: September 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Pancreatic Cancer
Proton radiation

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases processed this record on November 25, 2014