Standard of Care Chemotherapy With or Without Stereotactic Body Radiation Therapy for Oligometastatic Pancreatic Cancer

NCT04975516 | Terminated Phase 2

• 3 other identifiers: MC210711NCI-2021-0700620-011610
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the effect of standard of care chemotherapy with or with out stereotactic body radiation therapy in treating patients with pancreatic cancer that has spread to a limited amount of places in the body (oligometastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with stereotactic body radiation therapy may help improve tumor control, decrease risk of tumor spreading more, decrease side effects, and prolong survival.

Conditions

Metastatic Pancreatic Adenocarcinoma; Stage IV Pancreatic Cancer AJCC v8; Recurrent Pancreatic Adenocarcinoma; Oligometastatic Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Disease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and will be documented at each enrolling site with no central review planned.

  Time from randomization to the first of either disease progression or death from any cause, assessed up to 2 years

Secondary Outcomes (3)

• Confirmed response rate

  Up to 2 years

• Overall survival

  Time from study entry to death from any cause, assessed up to 2 years

• Incidence of adverse events

  Up to 2 years

Study Arms (2)

Group I (SBRT, chemotherapy)

EXPERIMENTAL

Patients undergo SBRT QD or every other day for 5 fractions, and receive chemotherapy per standard of care.

Drug: Chemotherapy; Radiation: Stereotactic Body Radiation Therapy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Other: Questionnaire Administration

Group II (chemotherapy)

ACTIVE COMPARATOR

Patients receive chemotherapy per standard of care.

Drug: Chemotherapy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Other: Questionnaire Administration

Interventions

Chemotherapy DRUG

Given chemotherapy

Also known as: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

Group I (SBRT, chemotherapy); Group II (chemotherapy)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Tomography (CT) scan, CT, CT SCAN

Group I (SBRT, chemotherapy); Group II (chemotherapy)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Group I (SBRT, chemotherapy)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging (MRI), MRI, Magnetic Resonance / Nuclear Magnetic Resonance, MRI Scan, MRIs, NMRI, nuclear magnetic resonance imaging, sMRI, Structural MRI

Group I (SBRT, chemotherapy); Group II (chemotherapy)

Biospecimen Collection PROCEDURE

Undergo blood collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Group I (SBRT, chemotherapy); Group II (chemotherapy)

Questionnaire Administration OTHER

Ancillary studies

Group I (SBRT, chemotherapy); Group II (chemotherapy)

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years
• Histologically confirmed adenocarcinoma of pancreatic origin with pathologic material reviewed by the Department of Pathology at Mayo Clinic, if available and applicable
• Image proven oligometastatic pancreatic cancer patients (i.e., synchronous \& metachronous)
• Oligometastatic defined as: =\< 5 extracranial metastatic tumors (brain metastasis patients are excluded; indeterminate lung nodules stable on 2 consecutive imaging studies spaced more than 4 weeks apart will not count as sites of oligometastatic disease)
• All sites must be amenable to SBRT (positive peritoneal washings cytology or Kras cell free (cf)DNA, and positive peritoneal biopsy would be considered ineligible)
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• Non-measurable disease
• NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Negative pregnancy test done =\< 7days prior to registration, for women of childbearing potential only
• NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Ability to complete questionnaire(s) by themselves or with assistance
• Provide written informed consent
• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
• Willing to provide tissue and/or blood samples for correlative research purposes

You may not qualify if:

• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Any of the following prior therapies:
• Surgery =\< 3 weeks prior to registration
• Prior radiation to an overlapping area
• Co-morbid systemic 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
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Other active malignancy =\< 1 year prior to registration

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Publications (1)

• Elhariri A, Patel J, Mahadevia H, Modi K, Albelal D, Majeed U, Jones JC, Borad MJ, Tran NH, Rutenberg MS, Babiker H. Stereotactic body radiation therapy in oligometastatic pancreatic cancer: overall survival improvement and SMAD4 as a predictor of progression-free survival. J Gastrointest Oncol. 2025 Aug 30;16(4):1658-1666. doi: 10.21037/jgo-2025-100. Epub 2025 Aug 26.

  PMID: 40950337 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy; Radiosurgery; Magnetic Resonance Spectroscopy; Specimen Handling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Michael S. Rutenberg, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: July 18, 2023
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)