Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer (PC03)

This study is currently recruiting participants.
Verified April 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01553019
First received: October 21, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Pancreatic Cancer
Radiation: Proton radiation
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Postoperative Proton Radiotherapy With Concomitant Chemotherapy for Patients With Resected Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Radiation Toxicity [ Time Frame: 90 days after completion of RT ] [ Designated as safety issue: Yes ]
    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:
  • Survival Rate [ Time Frame: 1 year after completion of RT ] [ Designated as safety issue: No ]
    One year overall survival rate

  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: October 2011
Estimated Study Completion Date: February 2022
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Proton radiation with concomitant chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553019

Contacts
Contact: Intake Coordinator 877-686-6009

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    904-686-6009      
Principal Investigator: Romaine C Nichols, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Romaine C Nichols, MD University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01553019     History of Changes
Other Study ID Numbers: UFPTI 1013-PC03
Study First Received: October 21, 2011
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 22, 2014