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 States2 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 range
18 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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