A 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

Phase 1

• Conditions: Patients with pancreatic ductal adenocarcinoma; MedDRA version: 21.0Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003080-26-IT
• Lead Sponsor: FONDAZIONE GISCAD (GRUPPO ITALIANO PER LO STUDIO DEI CARCINOMI DELL'APPARATO DIGERENTE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-02
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 261

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
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 and Serum total bilirubin = 1.5 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 4 months after the last study treatment intake for women and 6 months for men;
12.Patient information and signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 61

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 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 and of other neoplasms without evidence of disease at least from 5 years;
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. T
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, Gilbert's disease or genotype UGT1A1 * 28 / * 28.
14.mutation in DPYD
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified