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 range18 Years – 75 Years
SexALL
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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.
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