A Study of Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-Metastatic Pancreatic Cancer

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 17-011198
    • Rochester, Minnesota: 17-011198
    NCT ID: NCT03902600
    Sponsor Protocol Number: ROR1741

About this study

The purpose of this study is to observe adverse events and effectiveness of hypofractionated concurrent chemoradiotherapy for the treatment of pancreatic cancer.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histological confirmation of adenocarcinoma of the pancreas (head, body, or tail of pancreas).
  • Imaging consistent with T1-4, N0-2,  M0 pancreas cancer, including potentially resectable, borderline resectable, or unresectable disease as per NCCN classification. When CT of the chest, abdomen, and pelvis are performed, this must be with contast per pancreas protocol. Imaging with a PET/MRI alone is acceptable on study. If a PET/CT is performed, a separate pancreas protocol CT is required for inclusion.
    • *Note: Imaging must be done prior to initiation of radiotherapy and does not need to be completed at time of enrollment.
  • Must have received neoadjuvant chemotherapy at the discretion of medical oncology.
  • Medical oncology consultation to confirm that patient is an appropriate candidate for concurrent chemotherapy, and surgical oncology consultation for confirmation of resection status.
    • Note: Consultation must be completed prior to initiation of radiotherapy and does not need to be completed at time of enrollment.
  • Patients who have received previous chemotherapy for pancreatic cancer are allowed to participate in this study, unless they experienced a previous allergic reaction to the drugs used in this study.
  • Planned to receive CRT, consisting of PBT or IMRT (45 Gy/15 fractions) with concurrent chemotherapy with 5 FU or Capecitabine.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 or Karnofsky Performance Status 70-100. 
  • Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB 15-000136*.
    • *Patients do not need to agree to Biobank blood draw. 
  • Able to complete standard of care clinical questionnaire(s) by themselves or with assistance.

Exclusion Criteria:

  • Presence of non-regional nodal involvement or distant metastatic disease (M1).
  • Prior radiotherapy resulting in overlap of radiation treatment fields.
  • History of prior malignancy < 2 years of enrollment, except non-melanotic skin cancer or carcinoma-in-situ of the cervix.
  • Immunocompromised patients and patients known to be HIV positive and not currently receiving antiretroviral therapy. 
    • Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Receiving any investigational agent concurrent with CRT which would be considered as a treatment for the primary neoplasm.
  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception.
  • Co-morbid systemic or psychiatric illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.        
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Terence Sio, M.D., M.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Merrell, M.D.

Open for enrollment

Contact information:

Jessica Schneider

(507)293-1230

Schneider.Jessica1@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20453013

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