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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Radiation: Moderately Hypofractionated RT

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with pancreatic cancer

Description

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.

  • 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 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

  • 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: 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

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Actual): November 11, 2021
• Study Completion (Actual): August 11, 2026

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: ROR1741 (Other Identifier: Mayo Clinic Radiation Oncology); 17-011198 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2021-13899 (Registry Identifier: CTRP (Clinical Trials Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No