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Proton Radiation for Resectable Carcinoma of the Pancreas (PC02)

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton radiation and chemotherapy
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Proton radiation, Chemotherapy, Xeloda, Gemzar, Resectable, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida Proton Therapy Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton radiation and chemotherapy

Arm Description

Proton radiation Capecitabine chemotherapy on radiation days Surgery Gemcitabine chemotherapy

Outcomes

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)

Secondary Outcome Measures

Collect and analyze tumor control outcomes

Full Information

First Posted
September 30, 2008
Last Updated
September 1, 2017
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00763516
Brief Title
Proton Radiation for Resectable Carcinoma of the Pancreas
Acronym
PC02
Official Title
A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 17, 2017 (Actual)
Study Completion Date
August 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, Proton radiation, Chemotherapy, Xeloda, Gemzar, Resectable, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton radiation and chemotherapy
Arm Type
Experimental
Arm Description
Proton radiation Capecitabine chemotherapy on radiation days Surgery Gemcitabine chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Proton radiation and chemotherapy
Other Intervention Name(s)
Xeloda, Gemzar
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Collect and analyze tumor control outcomes
Time Frame
1 year following the completion of radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romaine C Nichols, MD
Organizational Affiliation
University of Florida Proton Therapy Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Proton Radiation for Resectable Carcinoma of the Pancreas

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