Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreati… (NCT04894643) | Clinical Trial Compass
RecruitingNot Applicable
Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
Austria10 participantsStarted 2020-09-14
Plain-language summary
This is an interventional, single arm, open-label, feasibility trial with gemcitabine and nab-paclitaxel, followed by concomitant proton therapy and capecitabine, followed by re-evaluation and surgery (when feasible) for patients with borderline resectable pancreatic cancer.
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 with histologically or cytologically confirmed diagnosis of pancreatic cancer
* Diagnosis of borderline resectable cancer according to the international consensus definition 2017.
* Negative staging for distant metastasis
* Blood test within the following limits absolute neutrophil count \> 1,500 cells/mm³, platelet count \> 100,000 cells/mm³, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \< 2.5 times the upper limit of normal, total bilirubin \< 2.5 times the upper limit of normal if patient had recent biliary stenting, total bilirubin \< 1.5 times the upper limit of normal if no biliary stenting was done, serum creatinine within normal range (0.6-1.5 mg/dl) with a creatinine clearance \> 30 ml/min (as estimated by Cockroft Gault equation)
* Age \> 18 years
* Karnofsky index ≥ 70
* No tumor infiltration of stomach or duodenum
* The patient is informed of the diagnosis and is able to give informed consent (Ability of subject to understand character and individual consequences of the study protocol)
* Women of fertile age must have adequate conception prevention measures and must not breast feed
* Signed Informed Consent (must be available before study inclusion)
Exclusion Criteria:
* Non-exocrine tumors
* Major medical or psychiatric comorbidities that contraindicate radiation therapy, chemotherapy or surgery
* Presence of distant metastasis
* Pregnancy or unwilling to do adequate conception prevention
* Lactating and un…
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
Toxicity - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Timeframe: from enrollment to six months after surgery