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

Last updated: May 30, 2024
Sponsor: Proton Collaborative Group
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatic Cancer

Pancreatitis

Cancer

Treatment

Proton Radiation

Surgical resection

Capecitabine

Clinical Study ID

NCT02598349
PAN009-18
UFPTI-1510-PC04
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Biopsy proven unresectable adenocarcinoma of the pancreas.

  • Have either unresectable, borderline resectable or medically inoperable carcinoma ofthe pancreas, or refusing surgery.

  • A biliary obstruction is able to participate as long as a drainage tube is in placeprior to starting treatment with Proton radiation,

  • Participants of child-producing potential must be willing to use contraception whileon 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

Exclusion

Exclusion Criteria:

  • Evidence of distant metastasis.

  • Prior surgical resection.

  • Previous history of invasive malignancy (except non-melanoma skin cancer and low tointermediate 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 willingto use medically acceptable contraception while on treatment and for at least 12months thereafter.

  • Previous Radiation to the abdomen.

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Proton Radiation
Phase: 2
Study Start date:
April 01, 2016
Estimated Completion Date:
October 31, 2040

Study 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.

Connect with a study center

  • University of Florida Proton Therapy Institute

    Jacksonville, Florida 32206
    United States

    Active - Recruiting

  • Northwestern Medicine Chicago Proton Center

    Warrenville, Illinois 60555
    United States

    Active - Recruiting

  • McLaren Proton Therapy Center

    Flint, Michigan 48532
    United States

    Active - Recruiting

  • Inova Schar Cancer Institute

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.