Pulse-low-dose Rate (PLDR) Radiation in Pancreatic Cancer (NCT04452357) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pulse-low-dose Rate (PLDR) Radiation in Pancreatic Cancer
United States12 participantsStarted 2020-01-13
Plain-language summary
Standard chemoradiation, followed by surgery are standard treatment plan for patients suffering from pancreatic adenocarcinoma. Due to damage to the surrounding healthy tissue caused by standard radiation, this study uses a new type of radiation plan- pulsed low-dose rate (PLDR) radiation , in combination with chemotherapeutic drug, gemcitabine, given weekly along with the radiation.
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:
* Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma.
* Patients must have non-metastatic pancreatic cancer not appropriate for immediate surgical resection. This includes the following:
* Any involvement (defined as loss of fat plane on contrast CT) of any of the following vessels\*:
* Common hepatic artery
* Superior mesenteric artery
* Celiac axis
* Superior mesenteric vein
* Portal vein
* Aorta
* These criteria will be judged by the operating surgeon in conjunction with a radiologist prior to enrollment.
* Poor performance status not immediately conducive to radical surgery
* Other clinical reasoning by the treating physicians that supports pre-operative chemoradiation
* Patients must have evaluable disease as measured by RECIST 1.1 criteria.
* Planned surgical resection at the time of enrollment (may be initially staged as resectable, borderline resectable, or locally-advanced/unresectable).
* Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.
* Adequate bone marrow, hepatic, renal function.
* ANC ³ 1,500/ml and PLT ³ 100,000/ml
* Bilirubin less than 1.5 ULN
* AST and ALT \< 3X ULN
* Serum Creatinine \<1.5X ULN
* Prior chemotherapy allowed, but not mandatory. Patients who have undergone chemotherapy prior to participating in this study must have had a 2 week washout period at the time of signing the consent form.
* Women of childbearing potential mus…
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
Acute grade 3+ gastrointestinal toxicity possibly, probably or definitely related to radiation.