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Proton Therapy for Unresectable Cancer (CA) of Pancreas (PC01)

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:
NCT00685763
First received: May 22, 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 and chemotherapy has on you and your pancreatic cancer.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable 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 grade3+ bowel perforation, grade 3+ bleeding and grade4+ 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 measures [ Time Frame: 1 year following the completion of radiation therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: March 2008
Estimated Study Completion Date: July 2038
Estimated Primary Completion Date: July 2037 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton radiation and chemotherapy

Chemotherapy and Radiation Combination

Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.

Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.

Consolidation Chemotherapy starting 4 weeks after the completion of radiation

Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.

 Other: Proton radiation and chemotherapy

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

Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .

Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses

Other Names:
  • Capecitabine
  • Xeloda
  • Gemcitabine
  • Gemzar

Detailed Description:

Chemotherapy:Capecitabine on radiation days

Proton radiation over 7 weeks

Consolidation Chemotherapy:Gemcitabine

  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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685763

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: R. Charles Nichols, MD            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: R. Charles 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.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00685763     History of Changes
Other Study ID Numbers: UFPTI 0609-PC01
Study First Received: May 22, 2008
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Pancreatic cancer
Unresectable
Proton radiation
Chemotherapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
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 19, 2013