Chemotherapy with or without targeted radiation for limited pancreatic cancer spread
Phase 2 Randomized Trial of Standard of Care Chemotherapy With or Without Stereotactic Body Radiation Therapy for the Treatment of Oligometastatic Pancreatic Adenocarcinoma
This study is testing whether adding targeted radiation to standard chemotherapy can help people with limited spread of pancreatic cancer live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT04975516 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of standard chemotherapy combined with stereotactic body radiation therapy (SBRT) in patients with oligometastatic pancreatic cancer. The study aims to compare progression-free survival between patients receiving both treatments versus those receiving chemotherapy alone. Participants will undergo imaging and blood collection throughout the study to monitor their response and any adverse effects. The trial also includes a longitudinal assessment of patient-reported outcomes such as fatigue.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed oligometastatic pancreatic adenocarcinoma and no more than five extracranial metastatic tumors.
Not a fit: Patients with brain metastases or those whose tumors are not amenable to SBRT will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve tumor control and prolong survival for patients with oligometastatic pancreatic cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to registration) * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to registration) * Platelet count \>= 100,000/mm\^3 (obtained =\< 28 days prior to registration) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (If known Gilbert's syndrome, then =\< 3.0 x ULN) (obtained =\< 28 days prior to registration) * Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 28 days prior to registration) * Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained =\< 28 days prior to registration) * Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to registration) Exclusion Criteria: * 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 * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer * History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Michael S. Rutenberg, MD, PhD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.