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Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer (PC03)

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ClinicalTrials.gov Identifier: NCT01553019
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Proton radiation Drug: Gemcitabine Phase 2

Detailed Description:
Proton radiation with concomitant chemotherapy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Postoperative Proton Radiotherapy With Concomitant Chemotherapy for Patients With Resected Pancreatic Adenocarcinoma
Study Start Date : October 2011
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1- R(0) negative
50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Radiation: Proton 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

Drug: Gemcitabine
Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.
Other Name: Gemzar

Experimental: 2- R(1) micro-positive
54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Radiation: Proton 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

Drug: Gemcitabine
Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.
Other Name: Gemzar

Experimental: 3- R(2) gross positive
59.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Radiation: Proton 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

Drug: Gemcitabine
Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.
Other Name: Gemzar




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553019


Locations
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
United States, Tennessee
Provision Proton Therapy Center
Knoxville, Tennessee, United States, 37909
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Romaine C Nichols, MD University of Florida Proton Therapy Institute

Additional Information:
Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01553019     History of Changes
Other Study ID Numbers: UFPTI 1013-PC03
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Proton radiation
Chemotherapy
Pancreatic cancer
Postoperative

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs