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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorProton Collaborative Group

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Proton Radiation
  • Capecitabine
  • Surgical resection

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

Proton Collaborative Group

Lead sponsor

University of Florida Health

Collaborator