Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG (CASSANDRA TR… (NCT04793932) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG (CASSANDRA TRIAL)
Italy261 participantsStarted 2020-11-03
Plain-language summary
The main aim of this study is to compare the efficacy of short-course versus long-course pre-operative chemotherapy with PAXG or mFOLFIRINOX in patients who receive a diagnosis of pancreatic ductal adenocarcinoma (PDAC) resectable or borderline resectable.
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
✓. Cyto/histological diagnosis of pancreatic ductal adenocarcinoma\*;
✓. Clinical stage I-III disease according to TNM 8th Ed. 2017 \[appendix 1\];
✓. Resectable or borderline resectable disease, as anatomically defined according to NCCN Guidelines Version 1.2020 - Pancreatic Adenocarcinoma \[appendix 2\] and biologically defined according to the International consensus on definition and criteria of borderline resectable pancreatic ductal adenocarcinoma 2017 (CA 19.9 \> 500 IU/ml) (Isaji et al., 2018);
✓. Karnofsky Performance Status \> 60% \[appendix 3\];
✓. Age \> 18 and ≤ 75 years;
✓. Adequate bone marrow function (GB ≥ 3500/mm3, neutrophils ≥1500/mm3, platelets ≥ 100000/mm3, Hb ≥10 g/dl);
✓. Adequate kidney function (serum creatinine \< 1.5 mg/dL);
✓. Adequate liver function:
Exclusion criteria
✕. Other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cystadenocarcinoma and other periampullary malignancies.
✕. Prior (within 1 year) or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin
✕. Symptomatic duodenal stenosis;
What they're measuring
1
Event-free survival
Timeframe: 12 weeks
2
Event-free survival
Timeframe: 12 weeks
Trial details
NCT IDNCT04793932
SponsorAssociazione Italiana per lo Studio del Pancreas
. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
✕. Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
✕. Clinical stage IV (including ascites or malignant pleural effusion) disease according to TNM 8th Ed. 2017 \[appendix 1\];
✕. Locally advanced disease according to NCCN Guidelines Version 1.2020 - Pancreatic Adenocarcinoma \[appendix 2\];
✕. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to: