OXALIPLATIN for Small bowel adenocarcinoma

Inclusion criteria

• {"criterion_text":"- R0 resected stage I, II, III small bowel adenocarcinoma (SBA)"}
• {"criterion_text":"- Dated and signed informed consent prior to inclusion"}
• {"criterion_text":"- No residual or metastatic disease visible on CT/MRI TAP"}
• {"criterion_text":"- Patient to be registered and randomised within 12 weeks of surgery, and able to start chemotherapy within 14 weeks of surgery"}
• {"criterion_text":"- ECOG ≤ 1"}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Biological tests: neutrophils ≥ 2000/mm3; platelets ≥ 100000/mm3; haemoglobin ≥ 9 g/dL (prior transfusion possible) and bilirubin ≤ 1.5 x ULN."}
• {"criterion_text":"- ASAT et ALAT ≤ 2,5 x LSN"}
• {"criterion_text":"- Creatinine clearance > 50 mL/min (calculated using the Cockcroft Gault formula)"}
• {"criterion_text":"- Women of childbearing potential (post-menopausal women must have been amenorrhoeic for at least 12 months to be considered not of childbearing potential) must use contraception during treatment and for at least 4 months after stopping treatment; for male patients, contraception must be used during treatment and for at least 6 months after stopping treatment."}

Exclusion criteria

• {"criterion_text":"- Small bowel tumour with non-adenocarcinoma histology, including but not limited to lymphoma, GIST, carcinoid or other neuroendocrine tumours, squamous cell carcinoma, melanoma and sarcoma."}
• {"criterion_text":"- Known hypersensitivity to platinum salts"}
• {"criterion_text":"- Patients with an active, clinically significant infection or any other serious medical condition for which chemotherapy is contraindicated"}
• {"criterion_text":"- Patients with untreated vitamin B12 deficiency should not receive chemotherapy containing folinic acid. However, this patient may be eligible for capecitabine-based chemotherapy."}
• {"criterion_text":"- Patients with clinically significant neurosensorial hearing impairment should not receive oxaliplatin. However, this patient may be randomised in group 1 to either observation alone or fluoropyrimidine monotherapy."}
• {"criterion_text":"- Inability to comply with scheduled visits, therapeutic regimens, biological examinations and any other study procedures."}
• {"criterion_text":"- Neoadjuvant chemo(radio)therapy for SBA"}
• {"criterion_text":"- Clinically significant cardiovascular disease: active or < 12 months since stroke, myocardial infarction, unstable angina, congestive heart failure NYHA grade II or higher, severe cardiac arrhythmia requiring treatment, or uncontrolled hypertension."}
• {"criterion_text":"- History of cancer, except treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin, unless treated with curative intent and considered cured for at least 3 years."}
• {"criterion_text":"- Partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency, defined by uracilemia ≥ 16ng/ml"}
• {"criterion_text":"- Known untreated celiac disease (inclusion possible if controlled by diet), untreated chronic inflammatory bowel disease, or other causes of malabsorption or intestinal obstruction."}
• {"criterion_text":"- Peripheral neuropathy grade ≥ 2"}
• {"criterion_text":"- Pregnant and breast-feeding women"}
• {"criterion_text":"- Administration of any other investigational drug within 28 days prior to the first cycle of study treatment"}

Primary endpoints

• {"endpoint_text":"- Disease-free survival (DFS) is the primary endpoint of the study. It is defined as the time from randomisation to the first occurrence of the following events: - Recurrence of disease (confirmed by imaging) - Development of a new primary tumour (confirmed by imaging and histology/cytology) - Death Patients who do not present any of these events will be censored at the date of last news.","definition_or_measurement_approach":"Defined as the time from randomisation to the first occurrence of: recurrence of disease (confirmed by imaging), development of a new primary tumour (confirmed by imaging and histology/cytology), or death; patients without these events will be censored at date of last news."}

Secondary endpoints

• {"endpoint_text":"- Overall survival: the survival status of patients will be determined at each follow-up visit.","definition_or_measurement_approach":"Overall survival measured by determining survival status at each follow-up visit."}
• {"endpoint_text":"- Chemotherapy toxicity: toxicity will be assessed using the CTCAE version 4.0 classification. Only toxicities of at least grade 2 will be recorded in the CRF.","definition_or_measurement_approach":"Toxicity assessed using CTCAE v4.0; only toxicities grade ≥2 recorded in CRF."}
• {"endpoint_text":"- Quality of life: this will be assessed using the EORTC QLQ-C30, EORTC QLQ-CR29 and EQ-5D questionnaires.","definition_or_measurement_approach":"Quality of life measured using EORTC QLQ-C30, EORTC QLQ-CR29 and EQ-5D questionnaires."}
• {"endpoint_text":"- Health economics: to assess the cost-effectiveness of 24 weeks of adjuvant chemotherapy compared with observation alone, and of 24 weeks of adjuvant 5-FU/capecitabine monotherapy compared with 5-FU/capecitabine plus oxaliplatin. The results will be reported in terms of incremental cost per DFS and incremental cost per QALY.","definition_or_measurement_approach":"Cost-effectiveness analysis reporting incremental cost per DFS and incremental cost per QALY, comparing 24 weeks of adjuvant chemotherapy versus observation and monotherapy versus combination."}

France

Earliest CTIS Part Ii Submission Date

08-10-2024

Latest Decision Or Authorization Date

18-10-2024

Processing Time Days

10

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Dijon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France