Standard of Care Chemotherapy With or Without Stereotactic Body Radiation Therapy for Oligometast… (NCT04975516) | Clinical Trial Compass
TerminatedPhase 2
Standard of Care Chemotherapy With or Without Stereotactic Body Radiation Therapy for Oligometastatic Pancreatic Cancer
Stopped: Low/slow accrual
United States3 participantsStarted 2023-07-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Progression free survival
Timeframe: Time from randomization to the first of either disease progression or death from any cause, assessed up to 2 years