BALLAD BELGIUM: A trial to evaluate the potential benefit of adjuvant chemotherapy, that means a chemotherapy in addition to the curative surgery for small bowel adenocarcinoma
- Conditions
- small bowel adenocarcinomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-002831-65-BE
- Lead Sponsor
- Belgian Group of Digestive Oncology (BGDO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method