Moderately Hypofractionated Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-metastatic Pancreas Cancer With Assessment of Treatment Response Utilizing Molecular Biomarkers

Study Overview
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Brief Summary
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This study will observe side effects for patients who receive a 3-week course of radiation and chemotherapy for pancreas cancer. Blood samples will be collected before and after treatment to assess pancreas cancer DNA levels and its impact on outcomes.

Official Title
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Moderately Hypofractionated Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-metastatic Pancreas Cancer With Assessment of Treatment Response Utilizing Molecular Biomarkers

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Radiation: Moderately Hypofractionated RT


Participation Criteria
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Eligibility Criteria
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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, boarderline resectable, or unresectable disease as per NCCN classification. When CT of the chest, abdomen, and pelvis are performed, this must be with contras per pancreas protocol. Imagining with a PET/MRI alone is acceptable on study. If a PET/CT is performed, a separate pancreas protocol CT is required for inclusion. 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: 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 5FU or Capecitabine. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 or Karnofsky Performance Status 70-100 (Appendix III). 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. Patients at Mayo Clinic Arizona are not required to consent to the Registry. Willing to sign consent for blood collection onto the Pancreas SPORE, IRB 354-06. 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 RT to the thorax, abdomen, or pelvis 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Moderately Hypofractionated RT|Patients will be treated with moderately hypofractionated radiation treatment|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute grade 3 or higher GI AEs | acute grade 3 or higher GI AEs attributable to hypofractionated concurrent chemoradiotherapy (CRT) | 2 years after CRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late grade 3 or higher GI AEs | ate grade 3 or higher GI AEs attributable to hypofractionated concurrent CRT | 2 years after CRT | 
| local-regional recurrence | local-regional recurrence | 2 years after CRT | 
| progression free survival (PFS) | progression free survival (PFS) | 2 years after CRT | 
| overall survival | overall survival | 2 years after CRT or until death |