NCT04680260招募中2 期
OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer - a ctDNA Guided Phase II Randomized Approach
Karen-Lise Garm Spindler4 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2021年10月25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
- 350
- 试验地点
- 4
- 主要终点
- Recurrence Free Rate
研究概览
简要总结
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)
详细描述
An open label 1:1 randomized phase II exploratory study investigating use of ctDNA-guided adjuvant chemotherapy compared to standard of care (SOC) after local treatment for metastatic colorectal cancer.
Patients are randomized 1:1 between SOC and ctDNA guided treatment and follow-up.
Escalation therapy comprises standard regimen of Fluorouracil (5-FU), Irinotecan and oxaliplatin (FOLFOXIRI), de-escalation therapy of monotherapy capecitabine or observation only. SOC is per institutional practice, based on national guidelines.
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
- •Radical intended treatment for metastatic spread from CRC, by resection, radiofrequency ablation, stereotactic body radiation therapy (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC)
- •No evidence of further disease based on pre-treatment work-up according to SOC
- •Age at least 18 years
- •Eastern Cooperative Oncology Group performance status 0-2
- •Clinically eligible for adjuvant triple CT 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, abdomen, and pelvis
- •Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with triple combination chemotherapy
- •Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 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
- •Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabine
结局指标
主要结局
Recurrence Free Rate
时间窗: 2 years
Rate of patients free from recurrent colorectal cancer at 2 years post local treatment
次要结局
- Time to molecular biological recurrence(5 years last patient)
- Time to radiological recurrence(5 years last patient)
- Molecular biological response to therapy(6 months post-treatment)
- Local and distant relapse(5 years last patient)
- Overall survival(5 years last patient)
- Quality of life according to EQ-5D-5L(5 years last patient)
- Molecular biological Disease Free Survival(1 year from inclusion)
- Toxicity of treatment(6 months post-treatment)
- Cost-effectiveness analysis(5 years last patient)
- Quality of life according to EORTC QLQ-CR29 and -C30(5 years last patient)
研究者
Karen-Lise Garm Spindler
Professor
Aarhus University Hospital
研究点 (4)
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