ACTRN12617001566325招募中2 期
Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC-III)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Patients aged greater than or equal to 18 years of age
- •2.Subjects with curatively resected stage III (Any T, N1 or N2, M0) colon cancer
- •3.Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy and radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy.
- •4.A representative tumour sample is available for molecular testing up to 6 weeks after surgery
- •5.Fit for at least 3 months of fluoropyrimidine adjuvant chemotherapy
- •6.ECOG performance status 0-2
排除标准
- •1.History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in situ
- •2.Patients with multiple primary colorectal cancers
- •3.Inadequate organ function:
- •a.Moderate/severe renal impairment (GFR<30 ml/min), as calculated by the Cockcroft and Gault equation
- •b.Absolute neutrophil count <1.0x109/L
- •c.Platelet count <75x109/L
- •d.Haemoglobin <80 g/L
- •e. Aspartate aminotransferase/Alanine aminotransferase >2.5 x upper limit of normal
- •4.Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
研究者
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Circulating tumour DNA based decision for adjuvant treatment in colon cancer stage II evaluation (CIRCULATE) AIO-KRK-0217Colon cancer stage IIMedDRA version: 21.0Level: PTClassification code 10009954Term: Colon cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10038049Term: Rectal cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-003691-12-DETechnische Universität Dresden4,812
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CIRCULATEcolon cancer stage II, rectal cancer stage IIMedDRA version: 21.0Level: PTClassification code: 10009954Term: Colon cancer stage II Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10038049Term: Rectal cancer stage II Class: 100000004864CTIS2023-506715-18-00Technische Universitat Dresden140