Standard Chemotherapy With or Without Targeted Radiation for Pancreatic Cancer That Has Spread to a Few Places

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04975516

Provider View

This study is exploring whether adding targeted radiation therapy to standard chemotherapy can better control pancreatic cancer that has spread to a limited number of places in the body. The goal is to see if this combination can improve tumor control, reduce side effects, and help patients live longer.

Patient Parameters

Program Overview

This phase II clinical trial is investigating the effects of combining standard chemotherapy with or without a special type of radiation therapy called stereotactic body radiation therapy (SBRT) for patients with pancreatic cancer that has spread to a few places (oligometastatic). SBRT uses precise equipment to target tumors with high accuracy, potentially killing cancer cells with fewer doses and causing less harm to normal tissue. Chemotherapy works by stopping cancer cells from growing, dividing, or spreading. The study aims to find out if adding SBRT to chemotherapy can improve tumor control, reduce the risk of cancer spreading further, decrease side effects, and extend survival.

Description

PRIMARY OBJECTIVE:

  • Compare the time patients live without their cancer getting worse (progression-free survival) between those receiving SBRT plus standard chemotherapy and those receiving only standard chemotherapy.

SECONDARY OBJECTIVES:

  • Measure the confirmed response rate to the treatment.
  • Assess overall survival rates.
  • Monitor any side effects or adverse events.
  • Track changes in circulating tumor cells and tumor DNA over time.

CORRELATIVE RESEARCH OBJECTIVE:

  • Evaluate fatigue and other outcomes reported by patients.

OUTLINE: Patients are randomly assigned to one of two groups.

GROUP I: Patients receive SBRT once a day or every other day for a total of 5 sessions, along with standard chemotherapy.

GROUP II: Patients receive only standard chemotherapy.

After completing the study treatment, patients will have follow-up visits at 7 and 14 days, and then every 8-12 weeks for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of pancreatic cancer that has spread to a limited number of places (oligometastatic).
  • Cancer must be measurable by standard criteria.
  • Must be in good general health with an ECOG performance status of 0, 1, or 2.
  • Women of childbearing potential must have a negative pregnancy test within 7 days before joining the study.
  • Must be able to complete questionnaires on their own or with help.
  • Must agree to return to the study site for follow-up visits.
  • Must be willing to provide tissue and/or blood samples for research purposes.
  • Must have been treated with standard chemotherapy regimens and have stable disease for at least 4 months before joining the study.
  • Must have adequate blood counts and organ function as determined by specific lab tests.

Exclusion Criteria

  • Pregnant or nursing women.
  • Men or women of childbearing potential who are not using effective contraception.
  • Recent surgery within 3 weeks before joining the study.
  • Previous radiation to the same area being studied.
  • Severe health conditions that could interfere with the study.
  • Uncontrolled illnesses such as infections, heart failure, or psychiatric conditions.
  • Participation in another investigational treatment for cancer.
  • Other active cancers within the past year, except for certain skin or cervical cancers.
  • Recent heart attack or severe heart failure requiring ongoing treatment.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.