Fluorouracil for Ampullary adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Histologically proven adenocarcinoma on surgical specimen"}
• {"criterion_text":"- Macroscopically complete surgical resection of an ampullary adenocarcinoma (R0 or R1)"}
• {"criterion_text":"- Adenocarcinoma removed within 12 weeks prior to enrollment"}
• {"criterion_text":"- Patient without metastatic disease on CT scan < 4 weeks prior to inclusion"}
• {"criterion_text":"- CA19.9 level < 180 U/L at inclusion (post-operative level)"}
• {"criterion_text":"- Patients ≥ 18 years of age"}

Exclusion criteria

• {"criterion_text":"- Neoadjuvant systemic chemotherapy"}
• {"criterion_text":"- AST or ALT > 2.5 x UNL, alkaline phosphatase > 2.5x normal at least 15 days after resection"}
• {"criterion_text":"- Patients with poor nutritional status represented by albuminemia < 30.0g/dl"}
• {"criterion_text":"- History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure"}
• {"criterion_text":"- pT1N0M0 tumors"}
• {"criterion_text":"- Active infection by HBV, HCV or HIV"}
• {"criterion_text":"- Known dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng/mL)"}
• {"criterion_text":"- Pre-existing peripheral neuropathy (grade ≥ 2)"}
• {"criterion_text":"- Unresolved or uncontrolled concomitant medical conditions"}
• {"criterion_text":"- Neutrophils < 1500/mm3, platelets < 150 000/mm3, Haemoglobin < 9 g/dL"}
• {"criterion_text":"- Total bilirubin > 1.5x normal"}
• {"criterion_text":"- Creatinine clearance < 50 ml/min according to MDRD"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the 2 years Disease-free survival rate. DFS will be calculated from date of randomization to the date of first relapse (locally and/or metastatic) or date of death (all causes). Patients alive without relapse will be censored at the date of last news. Second cancer will not be considered as an event. The relapse will be assessed by the investigator according to RECIST v1.1 criteria.","definition_or_measurement_approach":"DFS calculated from date of randomization to first relapse or death (all causes); patients alive without relapse censored at last contact; second cancer not considered an event; relapse assessed by investigator according to RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- OS is defined as the time between randomization and death (all causes). Patients alive will be censored at the date of last news.","definition_or_measurement_approach":"Overall survival measured from randomization to death (all causes); censor at last contact if alive."}
• {"endpoint_text":"- Rate of patients completing 3 and 6-month chemotherapy schedule according to percentage of administered dose of each product. Percentage of administrated dose will be calculated as the ratio of dose received over dose planned for each product. A completed cycle will be defined by at least 80% of each product dispensed","definition_or_measurement_approach":"Completion rate defined by percentage of administered dose (dose received / dose planned); a completed cycle defined as ≥80% of each product dispensed."}
• {"endpoint_text":"- All grade and grade 3-4, will be described using NCI-CTCAE (National Cancer Institute – Common Terminology Criteria for Adverse Events) version 5.0","definition_or_measurement_approach":"Adverse events graded and reported according to NCI-CTCAE v5.0."}
• {"endpoint_text":"- Quality of life will be assessed according to the questionnaire of EORTC QLQ-C30 and PAN26 questionnaires.","definition_or_measurement_approach":"Quality of life measured using EORTC QLQ-C30 and PAN26 questionnaires."}

France

Earliest CTIS Part Ii Submission Date

16-09-2024

Latest Decision Or Authorization Date

29-08-2025

Processing Time Days

347

Number Of Participants

294

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Dijon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"Fondation Franc.Cancerologie Digestive","duties_or_roles":"[1,10,14,5,6,8,9]","organisation_type":"Hospital/Clinic/Other health care facility"}