Protocol Summary

Protocol No.: OCR14759

Sponsor Protocol No.: PAN009-18; PC04

Protocol Title.: Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas

Principal Investigator: Nichols, Romaine

Objective: 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).

Description: Participants as part of this research study will receive Proton radiation over 6 weeks with oral chemotherapy (capecitabine) only taken on radiation days. In addition, If surgery is an option, then surgical resection will be performed at least 8 weeks after treatment with radiation and chemotherapy. Quality of Life questionnaires are a part of this study.The Fact-Hep questionnaires will be filled out by the participant at strategic time points in the treatment course.

Phase: Phase II (Cancer Control)

Age Group: Adult

Age: 18 Years - N/A

Gender: All

Scope: Local

Treatment:
40.50 Gy (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) with:
Concomitant capecitabine (1,000 mg PO BID) on radiation treatment days.
Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.

Detailed Eligibility:
INCLUSION CRITERIA:
1. Ages 18 Years and older
2. Biopsy proven unresectable adenocarcinoma of the pancreas.
3. Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
4. A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
5. Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
6. Required pretreatment laboratory parameters:
7. Absolute granulocyte count (AGC/ANC) ≥ 1.8 thou/mm3
8. Platelet count ≥ 100,000/mm3
9. Bilirubin < 2 mg/dl
10. ALT/SGPT < 3x upper limit of normal
11. Creatinine < 3 mg/dl

EXCLUSION CRITERIA:
1. Evidence of distant metastasis.
2. Prior surgical resection.
3. 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.
4. Active or untreated infection,
5. 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.
6. Previous Radiation to the abdomen.

Applicable Conditions:

  • Pancreatic Cancer
  • Participation Institution:

  • No UF Health MRN : Robin Toton Cacchio
  • UF Jacksonville : Robin Toton Cacchio
  • Contact:
    Robin Toton Cacchio
    Phone: +1 904-588-1460
    Email: rtoton@floridaproton.org

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02598349