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Trial record 63 of 267 for:    Pancreatic Cancer AND Resectable

Proton Radiation for Resectable Carcinoma of the Pancreas (PC02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00763516
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : September 6, 2017
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Proton radiation and chemotherapy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2009
Actual Primary Completion Date : August 17, 2017
Actual Study Completion Date : August 17, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Collect and analyze tumor control outcomes [ Time Frame: 1 year following the completion of radiation therapy ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00763516

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United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
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Principal Investigator: Romaine C Nichols, MD University of Florida Proton Therapy Institute

Additional Information:
Crane unpublished data presented at ASCO GI, 2006-Abstract # 106; Das, P., et al.).

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Responsible Party: University of Florida Identifier: NCT00763516     History of Changes
Other Study ID Numbers: UFPTI 0704-PC02
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Pancreatic Cancer
Proton radiation
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gastrointestinal Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs