EUCTR2021-000507-20-ES进行中（未招募）1 期
Phase II randomized trial to assess the effect of intensive vs standard adjuvant chemotherapy in localised colon cancer with circulating tumor DNA
Instituto de Investigación Sanitaria INCLIVA0 个研究点目标入组 164 人开始时间: 2021年10月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 164
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.CIRCULATE-SPAIN-01 trial written informed consent.
- •2.Age = 18 years and = 75 years.
- •3.Histologically confirmed diagnosis of operable stage II or stage III Colon Cancer.
- •4.Postoperative, ctDNA positive
- •5.ECOG performance status 0-1.
- •6.Normal organ functions
- •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 82
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 82
排除标准
- •1.Patients having an MSI-H/MMRd tumor are excluded from the study (done according to standard clinical practice).
- •2.History of another neoplastic disease, unless in remission for = 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- •3.Had an incomplete diagnostic colonoscopy and/or polyps’ removal for patients in whom the remaining colon was not removed or explored. Note: Patients with intraoperative complete colonoscopy or early perioperative complete colonoscopy.
- •4.Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage).
- •5.Current treatment with another investigational drug or participation in another investigational study.
- •6.Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- •7.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- •8.Inadequate contraception (male or female patients) if of childbearing or procreational potential.
- •9.Current clinically unconcluded cardiovascular disease.
- •10. Acute or subacute intestinal occlusion or history of inflammatory bowel disease.
- •11. Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment.
- •12. Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency.
- •13. Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant.
- •14.Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required.
- •15.Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection. Note: no testing for Hepatitis B and Hepatitis C is required.
- •16. Has a known history of active TB (Bacillus Tuberculosis).
研究者
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