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RECRUITING Phase 2 ClinicalTrials.gov

Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas

Sponsor: Proton Collaborative Group • ClinicalTrials.gov ID: NCT02598349

Registry updated: 2026-09-29
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Description

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).

Interventions

  • Proton Radiation (Radiation)
    Proton Radiation 40.50 Gy relative biological effectiveness (RBE) in 18 fractions to gross disease and elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease. Total dose 63 Gy (RBE) in 28 fractions over 6 weeks.
  • Capecitabine (Drug)
    Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
  • Surgical resection (Procedure)
    Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.

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.

Conditions

Pancreatic Cancer

Locations

  • Proton Center of Arkansas — Little Rock, Arkansas, United States
  • University of Florida Proton Therapy Institute — Jacksonville, Florida, United States
  • Northwestern Medicine Chicago Proton Center — Warrenville, Illinois, United States
  • McLaren Proton Therapy Center — Flint, Michigan, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record