NCT02598349RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 4 Nov 2015
- Start date
- 1 Apr 2016
- Primary completion date
- 31 Oct 2039
- Lead sponsor
- Proton Collaborative Group
- Diseases
- Pancreatic cancer
- NCT number
- NCT02598349
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Apr 2016 to the primary completion date, 31 Oct 2039
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior surgical resection.
- Previous Radiation to the abdomen.
Other illness
- 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,
Other
- Evidence of distant metastasis.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McLaren Proton Therapy Center Coordinator of this site? Confirm its status | Flint | United States | Recruiting |
| University of Florida Proton Therapy Institute Coordinator of this site? Confirm its status | Jacksonville | United States | Active, not recruiting |
| Proton Center of Arkansas Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Northwestern Medicine Chicago Proton Center Coordinator of this site? Confirm its status | Warrenville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.