Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- DFS
研究概览
简要总结
A open label 1:1 randomized phase II exploratory study investigating adjuvant therapy in patients with molecular biologically detectable residual disease after primary resection for localized colorectal tumors.
详细描述
The main clinical hypothesis is that patients having undergone radical resection from CRC do not present with detectable tumor DNA in the plasma, whereas patients with detectable tumor DNA two weeks' post surgery have residual microscopic disease, and consequently a high risk of diseases recurrence which can be prevented with adjuvant chemotherapy.
The primary aim of the present study is to investigate - in a randomized trial - if use of standard adjuvant chemotherapy therapy improves the disease free survival in patients with molecular biological residual disease where adjuvant chemotherapy is not standard treatment .
Secondary aims include investigating molecular biological response to adjuvant chemotherapy in patients with post-operative ctDNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgically removed Adenocarcinoma of the colon or rectum
- •Pathologically stage I or II disease, and radical resection
- •Detectable ctDNA in two weeks postoperative plasma sample
- •No indication for adjuvant chemotherapy according to DCCG guidelines (website)
- •Age at least 18 years
- •ECOG performance status 0-2
- •Clinically eligible for adjuvant chemotherapy at investigators decision.
- •Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and Calculated or measured renal glomerular filtration rate at least 30 mL/min)
- •Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable •
- •Written and verbally informed consent
排除标准
- •Radiological evidence of distant metastasis, by CT- chest and abdomen
- •Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
- •Previous treatment with 5FU or oxaliplatin
- •Neuropathy NCI grade > 1
- •Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri
- •Pregnant (positive pregnancy test) or breast feeding women
研究组 & 干预措施
A
Intensified follow-up schedule
干预措施: Intensified Follow-up Schedule (Other)
B
Adjuvant chemotherapy + intensified follow-up schedule
干预措施: Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy (Drug)
结局指标
主要结局
DFS
时间窗: 3 years
Disease free survival
次要结局
- Molecular biological response(6 months)
- MB-DFS(1 year)
- OS(5 years)
- TT-MBR(3 years)
- LRR(3 years)
- DRR(3 years)
- TR(3 years)
- TTR(3 years)
研究者
Karen-Lise Garm Spindler
Professor
Aarhus University Hospital