Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas
A Phase II Trial of Escalated Dose Proton Radiotherapy With Elective Nodal Irradiation and Concomitant Chemotherapy for Patients With Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma
- Pancreatic Cancer
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Proton Collaborative Group
- Enrolment target
- 60
- Started
- April 2016
- Main results due
- October 2039
- Study sites
- 4
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Biopsy proven unresectable adenocarcinoma of the pancreas. * Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery. * A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation, * Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter. * Required pretreatment laboratory parameters: * Absolute granulocyte count (AGC/ANC) ≥ 1.8 thou/mm3 * Platelet count ≥ 100,000/mm3 * Bilirubin \< 2 mg/dl * ALT/SGPT \< 3x upper limit of normal * Creatinine \< 3 mg/dl Exclusion Criteria: * Evidence of distant metastasis. * Prior surgical resection. * Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration. * Active or untreated infection, * Pregnant or breastfeeding women or subjects of child producing potential not willing to use medically acceptable contraception while on treatment and for at least 12 months thereafter. * Previous Radiation to the abdomen.
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(4)
Proton Center of Arkansas
Little Rock, Arkansas, United States
Recruiting
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Active, not recruiting
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States
Recruiting
McLaren Proton Therapy Center
Flint, Michigan, United States
Recruiting
Showing 4 of 4 sites. 3 of the 4 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT02598349. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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