Patients with pancreatic ductal adenocarcinoma MedDRA version: 21.0 Level: LLT Classification code 10033602 Term: Pancreatic adenocarcinoma resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: CISPLATINO SANDOZ - 1 FLAC 100 ML CONCENTRATO PER INFUSIONE 0.5 MG/ML
Product Name: Cisplatino
Product Code: [15663-27-1]
Pharmaceutical Form: Concentrate for solution for injection/infusi
Sponsors
FONDAZIONE GISCAD (GRUPPO ITALIANO PER LO STUDIO DEI CARCINOMI DELL'APPARATO DIGERENTE)
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 61
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare in terms of 1yr-EFS the efficacy of PAXG to that of mFOLFIRINOX. to compare in terms of 1yr-EFS the efficacy of 4 months pre-operative and 2 months postoperative chemotherapy to that of 6 months of pre-operative chemotherapy;Secondary Objective: OS, RECIST response rate, CA19.9 response rate, and complete pathologic response, resectability rate, surgical mortality and morbidity rate, intra- and post-operative metastasis rate, N0 and R0 resections rate, patients reported outcomes, and treatment toxicity;Primary end point(s): EFS, CA19-9 failure recurrence; preoperative or intraoperative unresectability; intraoperative evidence of metastases; death for any cause; whichever occurs first.;Timepoint(s) of evaluation of this end point: EFS, defined as the time from randomization to: RECIST progression [At least a 20% 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%, 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%, 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): EFS, CA19-9 failure recurrence; preoperative or intraoperative unresectability; intraoperative evidence of metastases; death for any cause; whichever occurs first.;Timepoint(s) of evaluation of this end point: EFS, defined as the time from randomization to: RECIST progression [At least a 20% 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%, 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%, 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. | — |
Countries
Italy
Contacts
Public ContactUfficio Operativo
Fondazione GISCAD
Outcome results
None listed