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Proton Radiotherapy for Upper Gastrointestinal Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01449864
Recruitment Status : Completed
First Posted : October 10, 2011
Results First Posted : November 4, 2019
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
The primary objectives are to determine feasibility and the acute toxicity profile of proton therapy with concurrent continuous infusion 5-FU chemotherapy. Secondary objectives are to determine late toxicities and to generate preliminary data on clinical efficacy.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Radiation: Proton therapy Not Applicable

Detailed Description:
This protocol invites patients with cancer of the upper digestive tract who will receive simultaneous proton radiation therapy and chemotherapy. The purpose of this study is to use a newer form of radiation therapy called proton radiation and to determine if its use is safe and effective in people with this type of cancer. Doctors will assess the safety of this method of treatment, record the side effects participants experience while receiving the standard dose of proton radiation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility and Registration Study of Proton Radiotherapy for Upper Gastrointestinal Malignancies
Study Start Date : August 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Proton RT
Subjects receive proton radiation
Radiation: Proton therapy
The goal of radiation therapy is to deposit the majority of the radiation dose to the target while minimizing the dose to the surrounding normal tissues.




Primary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: 90 days ]
    Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.

  2. Acute Toxicity [ Time Frame: 90 days ]
    Measured by experience of adverse events



Information from the National Library of Medicine

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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:

  • Patients with histologic diagnosis of adenocarcinoma of the upper gastrointestinal tract, including patients with any of the following diagnoses and settings who are candidates to receive radiation which concurrent continuous infusion 5-FU chemotherapy: Pancreatic adenocarcinoma (unresected and adjuvant), Duodenal adenocarcinoma (unresected or adjuvant), Cholangiocarcinoma (unresected or adjuvant), Gastric adenocarcinoma (unresected or adjuvant), Gastroesophageal junction adeno carcinoma (adjuvant)
  • Patient must be >18 years of age.
  • Patient must have an ECOG Performance Status of 0-2, and a life expectancy of greater than or equal to 3 months.
  • Patient must be able to provide informed consent.
  • Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.

Exclusion Criteria:

  • Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
  • Pregnant women, women planning to become pregnant and women that are nursing.
  • Patients who experience surgical complications which prevent radiation from starting for 3 months or more.

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): NCT01449864


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: John Plastaras, MD, PhD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01449864    
Other Study ID Numbers: UPCC 09211
First Posted: October 10, 2011    Key Record Dates
Results First Posted: November 4, 2019
Last Update Posted: April 15, 2020
Last Verified: April 2020
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
upper GI malignancies
concurrent chemoradiation with continuous infusion 5-Fluorouracil chemotherapy
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases