Evaluating the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma
- Conditions
- Small bowel adenocarcinomaCancer
- Registration Number
- ISRCTN15070952
- Lead Sponsor
- Greater Glasgow and Clyde Healthboard and University of Glasgow
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 69
Current participant inclusion criteria as of 12/07/2019:
1. R0 resected stage I, II, III or IV SBA
2. No evidence of residual or metastatic disease at laparotomy or on 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 = 16 years
13.Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures
Previous participant inclusion criteria:
1. R0 resected stage I, II or III SBA
2. No evidence of residual or metastatic disease at laparotomy or 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 = 16 years
13.Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures
Current participant exclusion criteria as of 12/07/2019:
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 SBA
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 treatments consisted of resection alone or with a single installation of intracescical 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 wih very low potential for recurrence can be discussed with the CI or his approved representative through the Glasgow CRUK Clinical Trials Unit where eligibility will be considered on an individual basis
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
Previous participant 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 [NYH
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>1. Disease relapse (confirmed by imaging)<br>2. Incidence of a new primary (confirmed by imaging and histology/cytology)<br>3. Death from any cause<br>Patients who experience none of these events are censored at the last date known to be alive.
- Secondary Outcome Measures
Name Time Method