Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma (NCT03822936) | Clinical Trial Compass
TerminatedPhase 2
Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma
Stopped: The study was early closed due to low accrual in August 2022.
Italy30 participantsStarted 2018-02-08
Plain-language summary
Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.
Who can participate
Age range
18 Years – 75 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:
* histologic/cytologic diagnosis of exocrine pancreas tumour
* resectable or borderline resectable exocrine pancreatic tumour (according to operability criteria)
* no metastasis from US, CT, PET, MRI or laparotomy
* Karnofsky index \>= 70
* stomach and duodenum not infiltrated by tumour
* given informed consent to study procedures
* Hb \> 9 g/dL, N\> 1500, PLT\> 100000
* creatininemia \< 1.5 mg/dL; bilirubinemia \< 1.5 times upper normal values; albumin \> 3 g/dL
* DPD normal activity
* contraception required and breast feeding not permitted
Exclusion Criteria:
* non resectable, locally advanced tumours
* insular cells tumour
* comorbidities excluding abdominal surgery and/or chemo- radiation therapy
* known metastasis
* DPD low activity
* inability to attend study procedures and follow ups
* pregnancy
* previous diagnosis of other tumour with more disadvantageous prognosis then the study object
* metallic biliary stent
* metallic prothesis or any other condition to prevent from target volume individuation and dose calculation
* clinical condition preventing from radiation therapy (i.e. infections in the irradiation area)
* medical and/or psychical condition preventing from radiation therapy
* past radiation therapy on abdomen.
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: The local progression free survival will be assessed at 1-year
Trial details
NCT IDNCT03822936
SponsorCNAO National Center of Oncological Hadrontherapy