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Completed

NCT Number: NCT00763516

Proton Radiation for Resectable Carcinoma of the Pancreas

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.

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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 and older

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 6 weeks

Surgery 6 weeks after radiation completion

Adjuvant Chemotherapy starting 2-8 weeks after surgery with Gemzar

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 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

Treatment and study plan

Proton radiation and chemotherapy

Radiation

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 outcomes

  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 outcomes

  1. Collect and analyze tumor control outcomes

    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 Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas

Acronym: PC02

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Oct 1, 2008
Registry last updated
Sep 6, 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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