EUCTR2019-002074-32-ES进行中（未招募）1 期
POST-SURGICAL LIQUID BIOPSY-GUIDED TREATMENT OF STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS - PEGASUS trial
IFOM - Istituto FIRC di Oncologia Molecolare0 个研究点目标入组 140 人开始时间: 2019年11月11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
- 140
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. Pegasus trial written informed consent.
- •2. Age = 18 years.
- •3. Histologically confirmed diagnosis of operable stage III or T4N0 stage II colon
- •cancer located 12 cm from the anal verge by endoscopy and above the peritoneal
- •reflection at surgery.
- •4. Availability of plasma collected prior to surgery.
- •5. Availability of the original FFPE tumor tissue.
- •6. Acceptance to undergo at least all the interventional liquid biopsies.
- •7. ECOG performance status 0-1.
- •8. Normal organ functions. (as defined in section 9.3)
- •9. Women with childbearing potential should complete a pregnancy test and be willing to
- •use highly effective contraceptive
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Patients having a 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.
- •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 or recent 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. Clinically relevant 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 Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant.
- •13. Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency.
- •14. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is
- •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 isrequired unless mandated by local health authority.
- •16. Has a known history of active TB (Bacillus
研究者
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