A Trial to Evaluate the Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, randomised, controlled, multi-centre, trial with disease free survival as the primary end point. The worldwide collaboration is referred to as GLOBAL BALLAD and consists of a number of individual parallel prospective studies addressing the same objectives with similar designs brought together under the framework of the International Rare Cancer Initiative. This protocol is for BALLAD BELGIUM, which is the component of GLOBAL BALLAD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belgian Group of Digestive Oncology
• Collaborators: Cancer Research UK; Kom Op Tegen Kanker
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

1. R0 resected stage I, II or III SBA

2. No evidence of residual or metastatic disease at laparotomy and on 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.

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 SBA

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 halflives, whichever is longer, prior to receiving the first dose of trial treatment.

10. Previous hypersensitivity to platinum salts

11. Patients with clinically significant, active infections, or any other serious medical condition in which chemotherapy is contraindicated will be excluded

12. 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

13. 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