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Brief Title: Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG (CASSANDRA TRIAL)
Official Title: A Randomized Phase II Trial of Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG Regimen for Stage I-III Pancreatic Ductal Adenocarcinoma (PDAC)
Study ID: NCT04793932
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 adenocarcinoma (PDAC) resectable or borderline resectable.
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 and only 10-20% of patients can be treated with a surgical resection. For this neoplasia, a radical resection may be an effective treatment. Nevertheless, results obtained with surgery alone are rather inadequate, showing a median survival of 12-14 months and 2-year survival of almost 20%: it seems evident the necessity to use complementary treatments in order to improve survival rate in this group of patients. Pancreatic cancer can relapse locally, at the level of tumoral bed, of the regional lymph nodes, on the immediately adjacent peritoneal surface or on contiguous organs. Also, distant metastases are quite frequent, mainly to the liver, at the entire peritoneal surface and, rarely, to the extra-abdominal organs. The rapid appearance of these metastases after surgical resection strongly suggests the presence of subclinical metastatic diffusion at an early phase of the disease. Currently, combination chemotherapy based on the mFOLFIRINOX regimen is considered the therapeutic standard in the adjuvant setting, in young and fit patients. Unfortunately, mFOLFIRINOX is burdened with strong haematological and extra-haematologic toxicity and just 2/3 of patients are able to complete the treatment. Recently, PAXG regimen \[(Cisplatin (P), Abraxane (A), Capecitabine (X), Gemcitabine (G)\] when compared to AG in randomized studies, showed an improvement in terms of progression-free survival (PFS) and overall survival in borderline resectable, locally advanced and metastatic patients. To date, several ongoing randomized trials are investigating the efficacy of perioperative or neoadjuvant strategies in early stage PDAC. Only few studies are available regarding neoadjuvant treatment: some are outdated, numerically inconsistent, retrospective, or not randomized. In this scenario, it aims to better investigate pre-operative therapeutic strategy. For this purpose, two randomizations are planned. 1. FIRST RANDOMIZATION. Eligible patients will be randomized (1:1), stratifying by basal CA19.9 level (\<5 ULN vs ≥ 5ULN) and centre to receive: PAXG or mFOLFIRINOX for 4 months 2. SECOND RANDOMIZATION. Patients without progression or limiting toxicity after 4 months of the assigned chemotherapy in the study, will be randomized (1:1), stratifying by treatment assigned by the first randomization, to receive 2 further months of the same chemotherapy either BEFORE or AFTER surgery.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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 Ospedale Generale Provinciale, Macerata, , 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 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
Name: Michele Reni, MD
Affiliation: IRCCS San Raffaele
Role: PRINCIPAL_INVESTIGATOR