A Feasibility and Registration Study of Proton Radiotherapy for Upper Gastrointestinal Malignancies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Serious Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Proton RT
Subjects receive proton radiation
Intervention: Proton therapy (Radiation)
Outcomes
Primary Outcomes
Serious Adverse Events
Time Frame: 90 days
Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.
Acute Toxicity
Time Frame: 90 days
Measured by experience of adverse events
Secondary Outcomes
No secondary outcomes reported