2024-517704-10-00招募中2 期
POST-SURGICAL LIQUID BIOPSY - GUIDED TREATMENT OF STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS - THE PEGASUS TRIAL
IFOM Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets11 个研究点 分布在 2 个国家目标入组 156 人开始时间: 2024年9月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 11
- 主要终点
- Number of post-surgery false negative cases after a double ctDNA-negative detection, defined as cases that become positive at subsequent interventional LB and/or that experience radiological relapse within 2 years.
研究概览
简要总结
The primary objective is to study the feasibility of using liquid biopsy to guide the post-surgical clinical management of stage III and high-risk stage II (T4N0) MSS colon cancer patients. Feasibility is defined as the ability of at least two subsequent post-surgical negative ctDNA determination to identify patients that will be NED (without radiologic evidence of metastasis) 2 years after surgery.
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
- •Pegasus trial written informed consent.
- •Age ≥ 18 years.
- •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.
- •Availability of the original FFPE tumor tissue.
- •Availability of plasma collected prior to surgery.
- •Acceptance to undergo at least all the interventional liquid biopsies.
- •ECOG performance status 0-
- •Normal organ functions.
- •Women with childbearing potential should complete a pregnancy test and be willing to use highly effective contraceptive methods.
排除标准
- •Patients having a MSI-H/MMRd tumor are excluded from the study (test done according to standard clinical practice).
- •Acute or subacute intestinal occlusion or history of inflammatory bowel disease.
- •Pre-existing neuropathy > grade
- •Known grade 3 or 4 allergic reaction to any of the components of the treatment.
- •Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant.
- •Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency.
- •Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required.
- •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 unless mandated by local health authority.
- •Has a known history of active TB (Bacillus Tuberculosis).
- •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.
- •Had an incomplete diagnostic colonoscopy and/or polyps removal.
- •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).
- •Current or recent treatment with another investigational drug or participation in another investigational study.
- •Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- •Inadequate contraception (male or female patients) if of childbearing or procreational potential.
- •Clinically relevant cardiovascular disease.
结局指标
主要结局
Number of post-surgery false negative cases after a double ctDNA-negative detection, defined as cases that become positive at subsequent interventional LB and/or that experience radiological relapse within 2 years.
Number of post-surgery false negative cases after a double ctDNA-negative detection, defined as cases that become positive at subsequent interventional LB and/or that experience radiological relapse within 2 years.
次要结局
- Disease-Free Survival (DFS) at 2 and 3-years, Overall Survival (OS) at 5- years.
- Safety and tolerability according to CTCAE version 5.0.
- Number of patients experiencing ctDNA seroconversion (i.e. ctDNA+ that become ctDNA-) after any chemotherapy regimen remaining disease free at 2 and 3 years.
- Assessment of QLQ-C30 and CR-29 EORTC questionnaires.
研究者
Silvia Marsoni
Scientific
IFOM Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets
研究点 (11)
Loading locations...
相似试验
招募中
2 期
Utility of analysis in blood of the evolution of the drug brigatinib for patients with lung cancer with ALK mutations2024-511317-38-00Fundacion GECP33
尚未招募
2 期
The Combined Role of FAPI PET and Liquid Biopsy in the Staging and Clinical Management of Bladder Cancer - FUTURE TrialBladder CancerNCT07257718Chiti Arturo262
尚未招募
不适用
Investigation of the ROle of faT and inflAmmaTory Cells in mElanomaNCT07293598The Christie NHS Foundation Trust20
尚未招募
不适用
Risk Factors for Postoperative Fever and Sepsis Following Retrograde Intrarenal SurgeryUrolithiasisNCT07295925TC Erciyes University250
招募中
2 期
Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)NCT07263919Akeso90