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Proton Radiation for Resectable Carcinoma of the Pancreas (PC02)

This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00763516
First received: September 30, 2008
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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

Surgery

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763516

Contacts
Contact: Intake Coordinator 877-686-6009

Locations
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
Investigators
Principal Investigator: Romaine C Nichols, MD University of Florida Proton Therapy Institute
  More Information

Additional Information:
Contact the University of Florida Proton Therapy Institute  This link exits the ClinicalTrials.gov site

Publications:
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
ClinicalTrials.gov Identifier: NCT00763516     History of Changes
Other Study ID Numbers: UFPTI 0704-PC02
Study First Received: September 30, 2008
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Pancreatic Cancer
Proton radiation
Chemotherapy
Xeloda
 Gemzar
Resectable
Surgery

Additional relevant MeSH terms:
Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gemcitabine
Capecitabine
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 16, 2013