EUCTR2013-003047-29-GB进行中（未招募）1 期
BALLAD UK. A trial to evaluate the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma. - BALLAD UK
Greater Glasgow and Clyde Health Board0 个研究点目标入组 120 人开始时间: 2015年1月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.R0 resected stage I, II, III or IV small bowel adenocarcinoma
- •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 14 weeks of surgery and
- •commence chemotherapy within 16 weeks of surgery
- •4.ECOG Performance Status of 0 or 1
- •5.Absolute neutrophil count of = 1.5 x10(9)/l
- •6.Platelet count = 100 x 10 (9)/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
- •12.Age = 16 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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •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 of the breast where treatment consisted of
- •resection alone
- •(ii) cervical carcinoma in situ where treatment consisted of resection alone
- •(iii) basal call or squamous cell carcinoma where treatment consisted or
- •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
- •(v) other cancers where the patient has been disease free for at least 3
- •years and treatment was with curative intent
- •(vi) other cancers with very low potential for recurrence can be discussed
- •with the CI or his approved representative through the Glasgow CRUL CTU 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
研究者
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