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Completed

NCT Number: NCT00685763

Proton Therapy for Unresectable Cancer (CA) of Pancreas

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

About this study

Chemotherapy:Capecitabine on radiation days

Proton radiation over 7 weeks

Consolidation Chemotherapy:Gemcitabine

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proton radiation and chemotherapy

Radiation

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

Chemotherapy:

Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F) Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses

Other names: Capecitabine, Xeloda, Gemcitabine, Gemzar

Primary outcomes

  1. Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)

    Time frame: 1 year following the completion of radiation therapy

Secondary outcomes

  1. Collect and Analyze Tumor Control Measures

    Time frame: 1 year following the completion of radiation therapy

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Acronym: PC01

Important dates

Study start
2008
Primary completion
2013
Study completion
2017
First posted
May 28, 2008
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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