SMALL BOWEL ADENOCARCINOMA
Conditions
Sponsors
Centre Hospitalier Universitaire (CHU) de Dijon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. R0 resected stage I, II or III small bowel adenocarcinoma 2. No evidence of residual or metastatic disease at laparotomy and CT/MRI imaging of chest, abdomen and pelvis. 3. Patients must be registered and randomised within 12 weeks of surgery and commence chemotherapy within 14 weeks of surgery 4. ECOG Performance Status of 0 or 1 5. Absolute neutrophil account = 1.5 x109/l 6. Platelet count = 100 x 109/l 7. Haemoglobin =90 g/l (previous transfusion is allowed) 8. AST and ALT = 2.5 x upper limit of normal (ULN). (At least one of ALT or AST MUST be performed) 9. Creatinine clearance > 50 ml/min (calculated by Cockcroft Gault or Wright equation) or measured by EDTA 10. Serum bilirubin = 1.5 x ULN 11. Signed and dated informed consent indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment. 12. Age = 18 years 13. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. 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. 2. Previous neo-adjuvant chemo(radio)therapy for small bowel adenocarcinoma 3. 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) 4. 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) 5. Previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease free interval of at least 3 years and treatment was with curative intent 6. Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency 7. Known untreated coeliac disease (may be enrolled if diet controlled), untreated chronic inflammatory bowel disease or other cause of malabsorption or intestinal obstruction 8. Grade = 2 peripheral neuropathy 9. Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to receiving the first dose of trial treatment. 10. Previous hypersensitivity to platinum salts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary oObjective of the trial is to assess: •the efficacy of observation against 24 weeks of adjuvant post-operative chemotherapy •the efficacy of 24 weeks of adjuvant post-operative 5-FU/Capecitabine monotherapy versus 5-FU/Capecitabine plus Oxaliplatin ;Secondary Objective: The secondary objectives are to: •Assess the toxicity of chemotherapy, the overall survivall, the cost-effectiveness of the treatment alternatives, the quality of life and establish a central tissue bank for patients with this rare cancer. ;Primary end point(s): Disease free survival is the primary end point for the trial. This is defined at time from randomisation to the first occurrence of the following events: •Disease relapse (confirmed by imaging) •Incidence of a new primary (confirmed by imaging and histology/cytology) •Death from any cause Patients who experience none of these events are censored at the last date known to be alive. ;Timepoint(s) of evaluation of this end point: At 3 years after the last patient is randomized | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival: The patient’s survival status is determined at each follow-up visit. After the mandated clinic visits survival status data will come from responsible cancer centres, cancer registries and national databases and include long-term passive follow-up data such as that collected through collaboration with the National Cancer Intelligence Network and the Office of National Statistics in the U.K. Toxicity of chemotherapy: Toxicity will be assessed using CTCAE version 4.0. Only toxicities that are at least grade 2 will be recorded on the CRF Quality of life: This is assessed using the EORTC QLQ-C30, EORTC QLQ-CR29 v2.1 and EQ-5D scales as per the schedule indicated in section 4.1.5 Health Economics: Assess the cost-effectiveness of 24 weeks adjuvant chemotherapy in comparison to observation alone; and assess the cost-effectiveness of 24 weeks adjuvant 5-FU/Capecitabine monotherapy compared to 5-FU/Capecitabine plus Oxaliplatin. Outcomes will be reported as incremental cost per DFS and incremental cost per QALY. Establishment of a central tissue bank for patients with SBA – further details on this tissue bank can be found in section 4.2, Translational Research. ;Timepoint(s) of evaluation of this end point: At 3, 5 and 7 years after the last patient is randomized | — |
Countries
France
Contacts
Public ContactMartina Schneider
Fédération Francophone de Cancérologie Digestive (FFCD)
Outcome results
None listed