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Completed

NCT Number: NCT01553019

Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy has on resected 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida Proton Therapy Institute, Jacksonville, Florida, United States

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About this study

Proton radiation with concomitant chemotherapy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection
  • Post resection CA19-9 tumor marker baseline

Exclusion criteria

  • Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the patient has been disease free for at least 5 years prior to study consent

Treatment and study plan

Proton Radiation

Radiation

Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction

Gemcitabine

Drug

Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.

Other names: Gemzar

Primary outcomes

  1. Radiation Toxicity

    Time frame: 90 days after completion of RT

    Assessment of acute/late severe (defined as grade 3-5) radiation toxicity at the completion of therapy. Acute toxicity will be defined to be toxicity occurring within 90 days from the start of radiation treatment, and late toxicity will be defined as toxicity occurring more than 90 days from the start of radiation treatment.

Secondary outcomes

  1. Survival Rate

    Time frame: 1 year after completion of RT

    One year overall survival rate

  2. Response rate via CA 19-9

    Time frame: Every 3 months for 2 years, then every 6 months for 3-5 years then annually thereafter

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

A Phase II Trial of Postoperative Proton Radiotherapy With Concomitant Chemotherapy for Patients With Resected Pancreatic Adenocarcinoma

Acronym: PC03

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2012
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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