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

Purpose

The purpose of the study is to improve 12 month survival from 50% to 75%, improve local and regional disease control and increase share of marginally resectable and unresectable patients being converted to resectable.

Inclusion Criteria:

  • 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/mm3Platelet 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.

Keywords

disease control, Radiotherapy, Nodal Irradiation, Concomitant Chemotherapy, Pancreatic Adenocarcinoma

Principal Investigator

Romaine C Nichols, Jr, M.D.

Department

MD-RADIATION ONCOLOGY

Contact Information

rnichols@floridaproton.org

9045881800


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