Actively Recruiting
Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas
Led by Proton Collaborative Group · Updated on 2025-09-09
60
Participants Needed
4
Research Sites
1278 weeks
Total Duration
On this page
Sponsors
P
Proton Collaborative Group
Lead Sponsor
U
University of Florida Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).
CONDITIONS
Official Title
Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven unresectable adenocarcinoma of the pancreas
- Have unresectable, borderline resectable, or medically inoperable pancreatic cancer, or refuse surgery
- Biliary obstruction allowed if drainage tube is placed before proton radiation
- Willingness to use contraception during treatment and for 12 months after if of child-bearing potential
- Pretreatment lab values: granulocyte count ≥ 1.8 thou/mm3, platelet count ≥ 100,000/mm3, bilirubin < 2 mg/dl, ALT/SGPT < 3x upper limit of normal, creatinine < 3 mg/dl
You will not qualify if you...
- Evidence of distant metastasis
- Prior surgical resection of pancreatic tumor
- Previous invasive malignancy except non-melanoma skin cancer or low/intermediate risk prostate cancer unless disease free for 5 years
- Active or untreated infection
- Pregnant or breastfeeding women or unwillingness to use contraception if of child-bearing potential
- Previous radiation to the abdomen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Active, Not Recruiting
2
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States, 60555
Actively Recruiting
3
McLaren Proton Therapy Center
Flint, Michigan, United States, 48532
Actively Recruiting
4
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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