small bowel adenocarcinoma
Conditions
Interventions
Trade Name: Fluorouracil Accord Healthcare 50 mg/ml, solution pour injection ou perfusion
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: FLUOROURACIL 50 mg /ml
Other descriptive name:
Sponsors
Belgian Group of Digestive Oncology (BGDO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. R0 resected stage I, II, III or IV 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 14 weeks of surgery and commence chemotherapy within 16 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. Female of child bearing potential (Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential) must use a method of contraception during treatment and at least 4 months after stopping treatment; for male patients this will be during treatment and for at least 6 months after stopping treatment 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
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.adenocarcinoma arising in the appendix or colorectum 3. Previous neo-adjuvant chemo(radio)therapy for small bowel adenocarcinoma 4. 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) 5. 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) 6. 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 7. Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency 8. Known untreated coeliac disease (may be enrolled if diet controlled), untreated chronic inflammatory bowel disease or other cause of malabsorption or intestinal obstruction 9. Grade = 2 peripheral neuropathy 10. Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to receiving the first dose of trial treatment. 11. Previous hypersensitivity to platinum salts 12. Patients with clinically significant, active infections, or any other serious medical condition in which chemotherapy is contraindicated will be excluded 13. 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 14. 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 15. Any patient receiving treatment with brivudine, sorivudine and analogues
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to assess: • the efficacy of observation against 24 weeks of adjuvant postoperative 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 survival, the cost-effectiveness of the treatment alternatives, the quality of life and establish a central tissue and data 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. 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 QLQCR29 v2.1 and EQ-5D scales as per the schedule indicated in section 4.1.4 Establishment of a central tissue and data 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
Belgium
Contacts
Public ContactClinical Trial Coordinator
Belgian Group of Digestive Oncology (BGDO)
Outcome results
None listed