Back to resultsProton Radiotherapy for Upper Gastrointestinal Malignancies
Primary Purpose
Gastrointestinal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton therapy
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Cancer focused on measuring upper GI malignancies, concurrent chemoradiation with continuous infusion 5-Fluorouracil chemotherapy
Eligibility 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.
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proton RT
Arm Description
Subjects receive proton radiation
Outcomes
Primary Outcome Measures
Serious Adverse Events
Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.
Acute Toxicity
Measured by experience of adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT01449864
First Posted
October 7, 2011
Last Updated
April 6, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01449864
Brief Title
Proton Radiotherapy for Upper Gastrointestinal Malignancies
Official Title
A Feasibility and Registration Study of Proton Radiotherapy for Upper Gastrointestinal Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
Keywords
upper GI malignancies, concurrent chemoradiation with continuous infusion 5-Fluorouracil chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proton RT
Arm Type
Experimental
Arm Description
Subjects receive proton radiation
Intervention Type
Radiation
Intervention Name(s)
Proton therapy
Intervention Description
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 Measure Information:
Title
Serious Adverse Events
Description
Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.
Time Frame
90 days
Title
Acute Toxicity
Description
Measured by experience of adverse events
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Plastaras, MD, PhD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Proton Radiotherapy for Upper Gastrointestinal Malignancies
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