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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment60 people
  • Recruiting US sites3
  • SponsorProton Collaborative Group
  • RegistryNCT02598349

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas: a one-minute explainerNCT025983491 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

capecitabine. A fluoropyrimidine carbamate belonging to the class of antineoplastic agents called antimetabolites. As a prodrug, capecitabine is selectively activated by tumor cells to its cytotoxic moiety, 5-fluorouracil (5-FU); subsequently, 5-FU is metabolized to two active metabolites, 5-fluoro-2-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP) by both tumor cells and normal cells. FdUMP inhibits DNA synthesis and cell division by reducing normal thymidine production, while FUTP inhibits RNA and protein synthesis by competing with uridine triphosphate for incorporation into the RNA strand. NCI Drug Dictionary

Treatments listed in the registry

  • 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.

The study

Treatment groups

Na · Single Group · masking: None

Proton Radiation with capecitabine (Experimental)

The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • surgery: Part of the study plan
  • radiation: Part of the study plan

Goals

What the study measures

Main goals

  • Overall survival at 12 months after radiation therapy (Approximately 12 months after radiation therapy.)

Other goals

  • Surgical resection rate.

Planned enrollment: 60 (estimated).

Where

Recruiting US sites

  • Proton Center of Arkansas, Little Rock, Arkansas
  • Northwestern Medicine Chicago Proton Center, Warrenville, Illinois
  • McLaren Proton Therapy Center, Flint, Michigan

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Background research

Papers linked by the registry

These papers are listed in the registry record. Unless a paper is marked as about this trial, it is background research on the treatment or disease, not results from this study.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 28, 2026. Public record; not medical advice.

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