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

Sponsor: Proton Collaborative Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02598349

Patient View

This trial evaluates proton radiation with capecitabine for pancreatic adenocarcinoma. Eligible patients have unresectable or borderline resectable tumors. Treatment involves 63 Gy proton radiation over 6 weeks with capecitabine on radiation days. Surgery is considered 8-16 weeks post-treatment if feasible. Participants must meet specific lab criteria and use contraception if of child-producing potential.

Patient Parameters

Program Overview

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

  • 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 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.

Get This Program In Your Inbox

You can sign up and apply your patients for this program.