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PAN009-18 (PC04): Protons for Unresectable, Borderline Resectable, or Medically Inoperable Panc

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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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.

Details

Full study title PAN009-18: 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 (PAN009-18)
Protocol number OCR14759
ClinicalTrials.gov ID NCT02598349
Phase Phase 2

Eligibility

  1. Ages 18 Years and older

  2. Biopsy-proven unresectable adenocarcinoma of the pancreas as defined by: ? Greater than 180 degree encasement of the superior mesenteric artery (SMA). ? Encasement of the celiac axis, hepatic artery, and or left gastric artery. ? Encasement or obstruction of the superior mesenteric vein (SMV) such that no reconstructive option is feasible. ? No evidence of metastatic disease in major viscera (organs), distant metastatic disease, ascites and/or peritoneal seeding. OR Biopsy-proven borderline resectable adenocarcinoma of the pancreas defined by: ? Abutment up to 180 degrees on the SMA. ? Reconstructable involvement of the SMV. ? Regional lymph node metastases. ? No evidence of metastatic disease in major viscera (organs), distant metastatic disease, ascites and/or peritoneal seeding. OR Patients with resectable tumors who are deemed medically inoperable or who refuse surgery.

Lead researcher

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    1

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

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  4. Step
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