Pancreatic CancerNCT03902600
A Study of Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-Metastatic Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Mayo Clinic at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Moderately Hypofractionated RT
- Type of treatment
- Surgery or procedure
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2018to 11 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with pancreatic cancer
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Moderately Hypofractionated RT
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderately Hypofractionated RTRadiation
Patients will be treated with moderately hypofractionated radiation treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 3 months after CRT
Secondary outcomes (4)
Late grade 3 or higher GI AEs
Late grade 3 or higher GI AEs attributable to hypofractionated concurrent CRT
Measured: 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.
Measured: 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.
Measured: 2 years after CRT
Overall survival (OS)
Defined as freedom from any cause of death, estimated from the time of registration.
Measured: 2 years after CRT or until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start10 May 2018
- Primary completion11 Nov 2021
- Study completion11 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth W. Merrell, MD, Principal investigator, Mayo Clinic in RochesterKrishan R. Jethwa, MD, Principal investigator, Mayo Clinic in RochesterTerence T. Sio, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902600
- Sponsor's protocol ID
- ROR1741
- Other IDs
- NCI-2021-13899, ROR1741, 17-011198
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2019
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderately Hypofractionated Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-metastatic Pancreas Cancer With Assessment of Treatment Response Utilizing Molecular Biomarkers
- ClinicalTrials.gov ID
- NCT03902600
- Acronym / sponsor ID
- ROR1741
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Aug 2026 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with pancreatic cancer
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderately Hypofractionated RTPatients will be treated with moderately hypofractionated radiation treatment | Radiation | – |
Primary outcome
Acute grade 3 or higher GI AEs
Time frame: Up to 3 months after CRT
Acute grade 3 or higher gastrointestinal (GI) adverse events (AEs) possibly, probably, or definitely related to hypofractionated concurrent chemoradiotherapy (CRT)
4 secondary outcomes
Late grade 3 or higher GI AEs
Time frame: 3 months to 2 years after CRT
Local-regional recurrence
Time frame: 2 years after CRT
Progression free survival (PFS)
Time frame: 2 years after CRT
Overall survival (OS)
Time frame: 2 years after CRT or until death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth W. Merrell, MD principal investigator
Mayo Clinic in Rochester
Krishan R. Jethwa, MD principal investigator
Mayo Clinic in Rochester
Terence T. Sio, MD, MS principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute grade 3 or higher GI AEs (time frame: Up to 3 months after CRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.