2024-518349-85-01招募中3 期
BALLAD Belgium - A trial to evaluate the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma. The Belgian component of the Global Ballad pooled data analysis.
Groupe Belge D'Oncologie Digestive8 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月20日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Disease free survival (defined as time from randomisation to recurrence, development of new primary or death from any cause).
研究概览
简要总结
Assessment of the efficacy of observation versus 24 weeks of adjuvant post-operative chemotherapy in resected stage I-IV small bowel adenocarcinoma (SBA). Assessment of the efficacy of 24 weeks of adjuvant post-operative fluoropyrimidine ‘monotherapy’ regimen versus fluoropyrimidine plus Oxaliplatin combination chemotherapy regimen in resected stage I-IV small bowel adenocarcinoma (SBA).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •R0 resected stage I, II, III or IV SBA
- •Serum bilirubin ≤ 1.5 x ULN
- •Signed and dated informed consent indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment.
- •Age ≥ 18 years
- •Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures.
- •No evidence of residual or metastatic disease at laparotomy and on CT/MRI imaging of chest, abdomen and pelvis.
- •Patients must be registered and randomised within 14 weeks of surgery and commence chemotherapy within 16 weeks of surgery
- •ECOG Performance Status of 0 or 1
- •Absolute neutrophil account ≥ 1.5 x10^9/l
- •Platelet count ≥ 100 x 10^9/l
- •Haemoglobin ≥90 g/l (previous transfusion is allowed)
- •AST and ALT ≤ 2.5 x upper limit of normal (ULN). (At least one of ALT or AST MUST be performed)
- •Creatinine clearance > 50 ml/min (calculated by Cockcroft Gault or Wright equation) or measured by EDTA
排除标准
- •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.
- •Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to receiving the first dose of trial treatment.
- •Previous hypersensitivity to platinum salts
- •Patients with clinically significant, active infections, or any other serious medical condition in which chemotherapy is contraindicated will be excluded
- •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
- •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
- •Any patient receiving treatment with brivudine, sorivudine and analogues
- •Adenocarcinoma arising in the appendix or colorectum
- •Previous neo-adjuvant chemo(radio)therapy for SBA
- •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)
- •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)
- •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 where eligibility will be considered on an individual basis
- •Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
- •Known untreated coeliac disease (may be enrolled if diet controlled), untreated chronic inflammatory bowel disease or other cause of malabsorption or intestinal obstruction
- •Grade ≥ 2 peripheral neuropathy
结局指标
主要结局
Disease free survival (defined as time from randomisation to recurrence, development of new primary or death from any cause).
Disease free survival (defined as time from randomisation to recurrence, development of new primary or death from any cause).
次要结局
- clinico-pathological, epidemiological and molecular profiling of SBA.
- Overall survival
- toxicity
研究者
Timon Vandamme
Scientific
Groupe Belge D'Oncologie Digestive
研究点 (8)
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