Fluorouracil for Small bowel adenocarcinoma

Inclusion criteria

• {"criterion_text":"- R0 resected stage I, II, III or IV SBA\n- No evidence of residual or metastatic disease at laparotomy and on CT/MRI imaging of chest, abdomen and pelvis.\n- Patients must be registered and randomised within 14 weeks of surgery and commence chemotherapy within 16 weeks of surgery\n- ECOG Performance Status of 0 or 1\n- Absolute neutrophil account ≥ 1.5 x10^9/l\n- Platelet count ≥ 100 x 10^9/l\n- Haemoglobin ≥ 90 g/l (previous transfusion is allowed)\n- AST and ALT ≤ 2.5 x upper limit of normal (ULN). (At least one of ALT or AST MUST be performed)\n- Creatinine clearance > 50 ml/min (calculated by Cockcroft Gault or Wright equation) or measured by EDTA\n- Serum bilirubin ≤ 1.5 x ULN\n- Signed and dated informed consent indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment.\n- Age ≥ 18 years\n- Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures."}

Exclusion criteria

• {"criterion_text":"- Non-adenocarcinoma histology of small bowel tumour which includes but is not confined to lymphoma, GIST, carcinoid or other neuroendocrine tumour, squamous carcinoma, melanoma or sarcoma.\n- Adenocarcinoma arising in the appendix or colorectum\n- Previous neo-adjuvant chemo(radio)therapy for SBA\n- Clinically significant cardiovascular disease (i.e. active or < 12 months since cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association [NYHA] grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension)\n- Pregnancy/lactation or of child bearing potential and not using medically approved contraception. (Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential)\n- Previous invasive or non-invasive malignancy except: (i) Ductal Carcinoma In Situ (DCIS) of the breast where treatment consisted of resection alone, (ii) Cervical carcinoma in situ where treatment consisted of resection alone, (iii) Basal cell or squamous cell carcinoma where treatment consisted of resection alone or radiotherapy, (iv) Superficial bladder carcinoma where treatment consisted of resection alone or with a single installation of intravesical chemotherapy or with BCG treatment, (v) Other cancers where the patient has been disease-free for at least 3 years and treatment was with curative intent, and (vi) Other cancers with very low potential for recurrence can be discussed with the CI where eligibility will be considered on an individual basis\n- Any patient receiving treatment with brivudine, sorivudine and analogues\n- Previous hypersensitivity to platinum salts\n- Patients with clinically significant, active infections, or any other serious medical condition in which chemotherapy is contraindicated will be excluded\n- Patients with untreated vitamin B12 deficiency are excluded from receiving folinic acid as part of their chemotherapy regimen. However, these patients may be eligible for treatment with capecitabine fluoropyrimidine therapy, where no folinic acid is administered as part of the treatment regimen\n- Patients with clinically significant sensorineural hearing impairment are excluded from receiving oxaliplatin but will be eligible for the fluoropyrimidine monotherapy provided as a clinician’s choice for patients in group 1 randomised to either observation or chemotherapy\n- Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency\n- Known untreated coeliac disease (may be enrolled if diet controlled), untreated chronic inflammatory bowel disease or other cause of malabsorption or intestinal obstruction\n- Grade ≥ 2 peripheral neuropathy"}

Primary endpoints

• {"endpoint_text":"- Disease free survival (defined as time from randomisation to recurrence, development of new primary or death from any cause).","definition_or_measurement_approach":"Defined as time from randomisation to recurrence, development of new primary or death from any cause."}

Secondary endpoints

• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- toxicity","definition_or_measurement_approach":""}
• {"endpoint_text":"- clinico-pathological, epidemiological and molecular profiling of SBA.","definition_or_measurement_approach":""}

Belgium

Earliest CTIS Part Ii Submission Date

15-11-2024

Latest Decision Or Authorization Date

20-11-2024

Processing Time Days

5

Number Of Sites

8

Number Of Participants

30

Primary sponsor

Full Name

Groupe Belge D'Oncologie Digestive

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"Kom op tegen Kanker-VZW","duties_or_roles":"Monetary support","organisation_type":""}