Active, not recruiting
Phase 3
Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG (CASSANDRA TRIAL)
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
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)
- Event-free survival — 12 weeks
to compare in terms of event free survival (EFS) the efficacy of PAXG to that of mFOLFIRINOX. EFS is defined as the time from randomization to: RECIST 1.1 progression \[At least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20 percent, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression\]; CA19.9 failure (defined as 2 consecutive increases of serum level ≥20 percent, separated by at least 4 weeks); recurrence; preoperative or intraoperative unresectability; intraoperative evidence of metastases; death for any cause; whichever occurs first. R1 resections will NOT be considered as events whereas R2 resections will be.
- Event-free survival — 12 weeks
to compare in terms of event free survival (EFS) the efficacy of 4 months pre-operative and 2 months postoperative chemotherapy to that of 6 months of pre-operative chemotherapy . EFS is defined as the time from randomization to: RECIST 1.1 progression \[At least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20 percent, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression\]; CA19.9 failure (defined as 2 consecutive increases of serum level ≥20 percent, separated by at least 4 weeks); recurrence; preoperative or intraoperative unresectability; intraoperative evidence of metastases; death for any cause; whichever occurs first. R1 resections will NOT be considered as events whereas R2 resections will be.
Trial sites (22)
| Facility | City | Region | Status |
| 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 |
|
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