Status:
ACTIVE_NOT_RECRUITING
Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG (CASSANDRA TRIAL)
Lead Sponsor:
Associazione Italiana per lo Studio del Pancreas
Collaborating Sponsors:
High Research srl
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Conditions:
Pancreas Ductal Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ad...
Detailed Description
Pancreatic cancer is the seventh cause of death in cancer patients and more than 94% of affected patients die of cancer disease. In the majority of cases, the diagnosis is done at an advanced stage an...
Eligibility Criteria
Inclusion
- 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:
- ALT and AST \< 3 ULN
- Serum total bilirubin ≤ 1.5 ULN or in subjects with biliary stenting ≤ 2 ULN;
- No prior treatment (chemotherapy, radiotherapy and/or surgery) for pancreatic cancer;
- Women must not be on pregnancy or lactation;
- 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. \[appendix 4\];
- Patient information and signed written informed consent.
Exclusion
- 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;
- 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:
- History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
- History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
- 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
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Any condition that confounds the ability to interpret data from the study
- Any familiar, sociologic or geographic conditions that can potentially interfere with the adhesion to the protocol or to the follow-up;
- Pre-existing neuropathy
- 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.)
- Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine.
- Concurrent treatment with other experimental drugs;
- Fructose intolerance.
Key Trial Info
Start Date :
November 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2026
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT04793932
Start Date
November 3 2020
End Date
January 31 2026
Last Update
April 9 2025
Active Locations (22)
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1
Oncologia Medica e Prevenzione Oncologica Centro di riferimento oncologico (CRO), IRCCS
Aviano, Italy, 33081
2
Oncologia Medica Az. Ospedaliera Istituto Tumori "Giovanni Paolo II"
Bari, Italy, 70124
3
Oncologia ASST pg23
Bergamo, Italy, 24127
4
Oncologia Medica Azienda Universitaria Ospedaliera Policlinico Sant'Orsola-Malpighi
Bologna, Italy, 40138