acetylsalicylic acid for Colon adenocarcinoma (resected) with PI3K mutation, stage III or high‑risk stage II

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Colonic adenocarcinoma stage III (N+,M0) or Colonic adenocarcinoma stage II high risk MSS: a.\t T4bN0 or T4a tumour penetrating the surface of the visceral peritoneum; b.\tT3N0 with less than 12 nodes evaluated; c.\tT3N0 with at least 12 nodes evaluated but at least two of the following criteria: i.\tlymphatic involvement, ii.\tperineural invasion, iii.\tvenous invasion; d.\tT3N0 with at least 12 nodes evaluated but at least one of the following criteria : i.\tdiagnosis of bowel obstruction or perforation; ii.\tpoor differentiated tumour.\n- PI3K mutation, exon 9 or 20 (tumour)\n- Status RAS known\n- Resection R0\n- WHO performance status 0-2\n- Chest and abdominal CT scan ≤ 12 weeks\n- Written consent signed\n- Women of childbearing age must agree to use effective contraception."}

Exclusion criteria

• {"criterion_text":"- Anticoagulant and/or Antiaggregating treatment including clopidogrel\n- Constitutional or acquired haemorrhagic disease include gastrointestinal bleeding, history of haemorrhagic and thrombotic stroke\n- Uncontrolled heart failure\n- Regular aspirin use (> 3 doses per week during more than 3 months the last year)\n- Follow-up of the patient not feasible for psychological, social or geographic reasons\n- Contraindication to Aspirin : Allergy to aspirin, Active or antecedent peptic ulcer\n- Severe renal or hepatic insufficiency\n- Pregnancy or nursing ongoing\n- Rectal cancer\n- Hereditary forms (i.e. lynch syndrome patients)\n- History of asthma induced by the administration of salicylate or close to active substances, including non-steroidal anti-inflammatory drugs"}

Primary endpoints

• {"endpoint_text":"- Disease free survival at 3 years defined as the time from date of randomisation to date of first local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first","definition_or_measurement_approach":"Defined as the time from date of randomisation to date of first local or distant recurrence or second colorectal cancer or death from any cause, whichever occurs first."}

Secondary endpoints

• {"endpoint_text":"- Disease-free survival at 5 years","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival at 5 years","definition_or_measurement_approach":""}
• {"endpoint_text":"- Compliance to aspirin (comptability of containers)","definition_or_measurement_approach":"Compliance assessed by collecting users' containers at each visit; number of remaining tablets documented."}
• {"endpoint_text":"- Severe bleeding grade 3-4 events and hospitalization according to NCI-CTC grading 4.0","definition_or_measurement_approach":"Events graded according to NCI-CTC version 4.0; severe bleeding defined as grade 3-4 and includes hospitalization."}
• {"endpoint_text":"- Adverse event reported and graded according to NCI-CTC grading 4.0","definition_or_measurement_approach":"AEs reported and graded per NCI-CTC version 4.0."}
• {"endpoint_text":"- Serious Adverse events will also be described","definition_or_measurement_approach":""}
• {"endpoint_text":"- Subgroups analyses regarding mutations (KRAS and BRAF) for DFS and OS","definition_or_measurement_approach":"Subgroup analyses by KRAS and BRAF mutation status for disease-free survival and overall survival."}

France

Earliest CTIS Part Ii Submission Date

16-08-2024

Latest Decision Or Authorization Date

25-09-2024

Processing Time Days

40

Number Of Sites

1

Number Of Participants

264

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France