Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 1,320
- 试验地点
- 32
- 主要终点
- Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.
研究概览
简要总结
Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design).
Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Age ≥ 18 years
- •Informed consent for PLCRC with specific consent for:
- •additional blood withdrawals
- •collection and use of tissue for scientific research
- •invitation for future (experimental) research within the cohort, including TwiCs studies
- •Inclusion in observational PLCRC -MEDOCC substudy
- •Histological confirmed stage II colon cancer
- •Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician
排除标准
- •Indication for adjuvant chemotherapy according to treating physician
- •Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma
- •Incomplete primary tumor resection (R1 or R2 resection)
- •Contra-indication for fluoropyrimidines or oxaliplatin
- •Pregnancy
研究组 & 干预措施
ctDNA-based treatment group
Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. Results are reported to the treating physician and patients. All patients with detectable ctDNA are considered high risk stage 2 patients and will be offered adjuvant chemotherapy for 3 months (4 cycles CAPOX) according to routine clinical practice. Patients with undetectable ctDNA will receive routine follow-up at the surgical department.
干预措施: ctDNA analysis after surgery (Other)
Standard of care group
The treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department.
结局指标
主要结局
Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.
时间窗: 8-12 weeks after surgery
次要结局
- Recurrence Rate(2 and 5 years after surgery)
- Disease Free Survival rate(2 and 5 years after surgery)
- Disease-related Overall Survival rate(5 years after surgery)
- Time to Recurrence(From date of randomization until the date of recurrence, assessed up to 5 years.)
- Quality of Life after treatment(10 years)
- Cost-effectiveness of the ctDNA-based treatment(5 years after diagnosis)