Protocol Summary

Protocol No.: OCR14759

Sponsor Protocol No.: PC04

Study Title
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.

Principal Investigator(s)
Nichols, Romaine

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/III (Cancer Control)

Age Group: Adult

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 10. ALT/SGPT 11. Creatinine
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 Disease Sites
Pancreatic Cancer

Participating Institutions
UF Jacksonville : Robin Toton

Contact
Robin Toton, RN
Phone: +1 904-588-1460

Email: rtoton@floridaproton.org

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