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

NCT03902600 | Active Not Recruiting

• 3 other identifiers: ROR1741NCI-2021-1389917-011198
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Late grade 3 or higher GI AEs

  3 months to 2 years after CRT

• Local-regional recurrence

  2 years after CRT

• Progression free survival (PFS)

  2 years after CRT

• Overall survival (OS)

  2 years after CRT or until death

Interventions

Moderately Hypofractionated RT RADIATION

Patients will be treated with moderately hypofractionated radiation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with pancreatic cancer

You may qualify if:

• Histological confirmation of adenocarcinoma of the pancreas (head, body, or tail of pancreas)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: May 10, 2018
• Primary Completion: November 11, 2021
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)