A Study Of Photon And Proton Chemoradiotherapy As Definitive Or Neoadjuvant Therapy In Non-Metastatic Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

RADIATION: Moderately Hypofractionated RT

ROR1741
NCI-2021-13899 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trials Reporting Program))
ROR1741 (OTHER Identifier) (OTHER: Mayo Clinic Radiation Oncology)
17-011198 (OTHER Identifier) (OTHER: Mayo Clinic Institutional Review Board)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-04-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-10-17
First Submitted that Met QC Criteria 2019-04-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-10-21
First Posted (ACTUAL) 2019-04-04	Results First Posted N/A	Last Verified 2024-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

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:

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Kenneth W. Merrell, MD, Mayo Clinic in Rochester

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record