Proton Radiotherapy for Upper Gastrointestinal Malignancies
Completed · Not applicable
Conditions studied: Gastrointestinal Cancer
In brief
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.
Key facts
- Study ID
- NCT01449864
- Run by
- Abramson Cancer Center at Penn Medicine
- People needed
- 22
- Starts
- 2011-08-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2020-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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