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Clinical Trials in Italy / NCT04793932
Active, not recruiting Phase 3

Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG (CASSANDRA TRIAL)

NCT04793932 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2020-11-03
Last updated
2025-04-09

Condition(s) studied

Pancreas Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

PAXGmFOLFIRINOX →short-course chemotherapylong-course chemotherapy

PAXG: Nab-paclitaxel, cisplatin and gemcitabine drugs will be administered on day 1 and 15 every 28 days. Capecitabine tablets will be taken orally on days 1 to 28, every 28 days

mFOLFIRINOX: Oxaliplatin, folinic acid, irinotecan and 5-Fluoruracil will be administered on day 1 and 15 every 28 days

short-course chemotherapy: other two months of chemotherapy after surgery

long-course chemotherapy: other two months of chemotherapy before surgery

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Cyto/histological diagnosis of pancreatic ductal adenocarcinoma\*; 2. Clinical stage I-III disease according to TNM 8th Ed. 2017 \[appendix 1\]; 3. 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); 4. Karnofsky Performance Status \> 60% \[appendix 3\]; 5. Age \> 18 and ≤ 75 years; 6. Adequate bone marrow function (GB ≥ 3500/mm3, neutrophils ≥1500/mm3, platelets ≥ 100000/mm3, Hb ≥10 g/dl); 7. Adequate kidney function (serum creatinine \< 1.5 mg/dL); 8. Adequate liver function: * ALT and AST \< 3 ULN * Serum total bilirubin ≤ 1.5 ULN or in subjects with biliary stenting ≤ 2 ULN; 9. No prior treatment (chemotherapy, radiotherapy and/or surgery) for pancreatic cancer; 10. Women must not be on pregnancy or lactation; 11. Patient of child-bearing potential must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for a minimum of the following 6 months; this applies to patients of both sexes. \[appendix 4\]; 12. Patient information and signed written informed consent. Exclusion Criteria: 1. Other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cystadenocarcinoma and other periampullary malignancies. 2. 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 3. Symptomatic duodenal stenosis; 4. 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 5. 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 6. Clinical stage IV (including ascites or malignant pleural effusion) disease according to TNM 8th Ed. 2017 \[appendix 1\]; 7. Locally advanced disease according to NCCN Guidelines Version 1.2020 - Pancreatic Adenocarcinoma \[appendix 2\]; 8. 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: 1. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa) 2. History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies 3. History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder 9. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 10. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 11. Any condition that confounds the ability to interpret data from the study 12. Any familiar, sociologic or geographic conditions that can potentially interfere with the adhesion to the protocol or to the follow-up; 13. Pre-existing neuropathy 14. c.1679GG, c.1905+1AA, c.2846TT mutations in homozygous in DPYD gene. Dose modification according to DPYD and UGT1A1 mutations are reported in Table 1 (https://www.aiom.it/wp-content/uploads/2019/10/2019\_Racc-analisi-farmacogenetiche.pdf.) 15. Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine. 16. Concurrent treatment with other experimental drugs; 17. Fructose intolerance.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Oncologia Medica e Prevenzione Oncologica Centro di riferimento oncologico (CRO), IRCCS Aviano Italy
Oncologia Medica Az. Ospedaliera Istituto Tumori "Giovanni Paolo II" Bari Italy
Oncologia ASST pg23 Bergamo Italy
Oncologia Medica Azienda Universitaria Ospedaliera Policlinico Sant'Orsola-Malpighi Bologna Italy
Oncologia Medica dell'Az.Ospedaliera Fondazione Poliambulanza Istituto Ospedaliero Brescia Italy
Oncologia Medica AOU Careggi Florence Italy
Oncologia Medica dell'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola Italy
Oncologia dell'Istituto Clinico Humanitas Milan Italy
IRCCS San Raffaele Milan Italy
Oncologia Medica Falck Niguarda Milan Italy
Oncologia Medica Az Ospedaliera AOU Cagliari Policlinico Universitario Dullio Casula Monserrato Italy
Oncologia Medica AOU FEDERICO II Naples Italy
Oncologia Medica 1 Ospedaliera Istituto Oncologico Veneto IRCCS Padova Italy
Oncologia Medica Arnas Civico Palermo Italy
Oncologia Medica 2 Az. Ospedaliera Universitaria Pisana Pisa Italy
Oncologia Ospedale Generale Provinciale Province of Macerata Italy
Oncologia Medica Az. Ospedaliera Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy
Chirurgia Generale e Oncologica dell'AZ. Ospedaliera Ordine Mauriziano Torino Italy
Divisione Chirurgica Az. Ospedaliera AULSS2 Treviso Italy
SOC di Oncologia Az. Ospedaliera Sanitaria Universitaria Friuli Centrale-P.O. "S. Maria della Misericordia" Udine Italy
Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata Verona Italy
Oncologia ULSS8 Berica Vicenza Italy

More Associazione Italiana per lo Studio del Pancreas trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04793932 on ClinicalTrials.gov ↗ ← All trials in Italy