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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-13899 | Registry Identifier | CTRP (Clinical Trials Reporting Program) | |
| ROR1741 | Other Identifier | Mayo Clinic Radiation Oncology | |
| 17-011198 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderately Hypofractionated RT | Radiation | Patients will be treated with moderately hypofractionated radiation treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Acute grade 3 or higher GI AEs | Acute grade 3 or higher gastrointestinal (GI) adverse events (AEs) possibly, probably, or definitely related to hypofractionated concurrent chemoradiotherapy (CRT) | Up to 3 months after CRT |
| Measure | Description | Time Frame |
|---|---|---|
| Late grade 3 or higher GI AEs | Late grade 3 or higher GI AEs attributable to hypofractionated concurrent CRT | 3 months to 2 years after CRT |
| Local-regional recurrence | Defined as disease recurrence within the residual pancreas, anastomosis, celiac or superior mesenteric plexus, or regional lymphatic stations with or without metastatic disease, estimated from the time of registration. Metastatic disease will be defined as tumor recurrence in a distant nodal or organ site. |
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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, borderline resectable, or unresectable disease as per National Comprehensive Cancer Network (NCCN) classification. When CT of the chest, abdomen, and pelvis are performed, this must be with contras per pancreas protocol. Imagining with positron emission tomography (PET)/magnetic resonance imaging (MRI) alone is acceptable on study. If 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.
Planned to receive CRT, consisting of proton beam therapy (PBT) or intensity-modulated radiation therapy (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, Institutional Review Board (IRB) 15-000136
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.
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:
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.
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Adult patients with pancreatic cancer
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth W. Merrell, MD | Mayo Clinic in Rochester | Principal Investigator |
| Krishan R. Jethwa, MD | Mayo Clinic in Rochester | Principal Investigator |
| Terence T. Sio, MD, MS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Rochester |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| 2 years after CRT |
| Progression free survival (PFS) | Defined as freedom from local-regional or metastatic progression or death of any cause, estimated from the time of registration. | 2 years after CRT |
| Overall survival (OS) | Defined as freedom from any cause of death, estimated from the time of registration. | 2 years after CRT or until death |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |