Active — Not RecruitingPhase 2

MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-Metastatic Pancreatic Cancer

United States23 participantsStarted 2015-12-10

Plain-language summary

This research study is for people who have pancreas cancer for which surgery is not recommended. Potential patients must have already received several months of chemotherapy before they are eligible for this study and there will not have been any detectable spread of their tumor on imaging studies following this chemotherapy course.

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: * Pathologically confirmed (histologic or cytologic), locally advanced, adenocarcinoma of the pancreas; patients must have unresectable disease based on institutional standardized criteria of unresectability or medical inoperability. * Participants with and without regional adenopathy are eligible. * No distant metastases, based upon the following minimum diagnostic workup: * History/physical examination, including collection of weight and vital signs, within 28 days prior to study entry; * Abdominal/pelvic CT scan with IV contrast within 21 days prior to study entry; * Chest CT scan, or X-ray within 21 days prior to study entry. * Abdominal/pelvic MR prior to radiation with perfusion and diffusion- weighted sequences and MR and CT sim for radiation planning Pet scan within 21 days prior to study entry, Functional renal study. * Zubrod performance status 0-1 within 1 week of study entry. * Age ≥ 18. * Hematology and cancer antigen (CA) 19-9 / carcinoembryonic antigen (CEA) within 14 days prior to study entry, as follows. * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3; * Platelets ≥ 100,000 cells/mm\^3; * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.); * Serum creatinine ≤ 1.5 mg/dl; * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 x upper limit of normal (ULN); * Total bilirubin \< 3.0 mg/dL; * Alkaline phosphatase \< 3 x ULN; * Fasting blood glucose \< 16…

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

Overall Survival

Timeframe: 1 and 2 years following up to 7 weeks of radiation treatment

Trial details

NCT IDNCT01972919

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-13

Results submitted2024-12-11

View on ClinicalTrials.gov More Unresectable Pancreatic Cancer trials