This trial is active, not recruiting.

Condition gastrointestinal cancer
Treatment proton therapy
Sponsor Abramson Cancer Center of the University of Pennsylvania
Start date August 2011
End date June 2013
Trial size 22 participants
Trial identifier NCT01449864, UPCC 09211


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Serious Adverse Events
time frame:
Acute Toxicity
time frame: 90 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Feasibility and Registration Study of Proton Radiotherapy for Upper Gastrointestinal Malignancies
Principal investigator John Plastaras, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Abramson Cancer Center of the University of Pennsylvania.