Status:
COMPLETED
Proton Radiotherapy for Upper Gastrointestinal Malignancies
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Gastrointestinal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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 rad...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01449864
Start Date
August 1 2011
End Date
December 1 2019
Last Update
April 15 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104