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

Tracking Information

First Received Date ^ICMJE

May 22, 2008

Last Updated Date

March 14, 2013

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

July 2037 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Collect and analyze tumor control outcomes [ Time Frame: after RT, then every 3 months during first two year; every 6 months during years 3-5; then annually ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00685763 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Collect and analyze tumor control measures [ Time Frame: 1 year following the completion of radiation therapy ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Collect and analyze morbidity outcomes of chemoradiation [ Time Frame: after RT, then every 3 months during first two year; every 6 months during years 3-5; then annually ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Proton Therapy for Unresectable Cancer (CA) of Pancreas

Official Title ^ICMJE

A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas

Brief Summary

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.

Detailed Description

Chemotherapy:Capecitabine on radiation days

Proton radiation over 7 weeks

Consolidation Chemotherapy:Gemcitabine

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pancreatic Cancer

Intervention ^ICMJE

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

Study Arm (s)

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.

Intervention: Other: Proton radiation and chemotherapy

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2038

Estimated Primary Completion Date

July 2037 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Intake Coordinator

877-686-6009

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00685763

Other Study ID Numbers ^ICMJE

UFPTI 0609-PC01

Has Data Monitoring Committee

Yes

Responsible Party

University of Florida

Study Sponsor ^ICMJE

University of Florida

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

R. Charles Nichols, MD

University of Florida Proton Therapy Institute

Information Provided By

University of Florida

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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