EUCTR2019-002074-32-IT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 Molecolare - Milano0 个研究点目标入组 140 人开始时间: 2020年10月7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 methods.
- •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 history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required.
- •14. 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.
- •15. Has a known history of active TB (Bacillus Tuberculosis).
研究者
相似试验
进行中（未招募）
1 期
POST-SURGICAL LIQUID BIOPSY-GUIDED TREATMENT OF COLON CANCER PATIENTSStage III and high-risk stage II colon cancerMedDRA version: 21.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002074-32-ESIFOM - Istituto FIRC di Oncologia Molecolare140
尚未招募
不适用
Assessment of Restenotic Neointimal Tissue after Second- or Third-Generation Drug-Eluting Stent Implantation: Evaluation by Histopathology, Optimal Coherence Tomography, and Intravascular UltrasoundCoronary Artery DiseaseJPRN-UMIN000032068The Cardiovascular Institute15
已完成
不适用
ong-Term Follow-Up of the Freestyle Stentless Bioprosthesisaortic root pathologyAortic valve pathology10046973NL-OMON40663eids Universitair Medisch Centrum250
招募中
2 期
Radiation treatment prior to surgery for local spine metastasisACTRN12615001031550Epworth HealthCare20
招募中
不适用
Follow-up study of endoscopic necrosectomy for severe acute pancreatitisacute pancreatitisJPRN-UMIN000034938Division of gastroenterology, Tohoku University30