Detection of Progressive Disease in Metastatic Colorectal Cancer Patients by NPY Methylation in Liquid Biopsies
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Optimize cutoff value
研究概览
简要总结
Detection of progressive disease by neuropeptide Y (NPY) methylation in liquid biopsies in patients with RAS and BRAF wild-type, unresectable, metastatic colorectal cancer receiving first-line treatment FOLFOX/FOLFIRI and panitumumab.
详细描述
Prospective, multicentric interventional study to optimize the cutoff value of NPY methylation in liquid biopsies in metastatic colorectal cancer patients treated with first-line FOLFOX/FOLFIRI and panitumumab.
Inclusion is possible after histologically or cytologically proven colorectal adenocarcinoma with metastatic lesions according to RECIST 1.1 at the start of first-line treatment using FOLFOX/FOLFIRI and panitumumab. Patient must have a proven RAS and BRAF wild-type tumor.
Patients will be followed by study protocol up to and including the first CT scan following the last liquid biopsies taken, or when a follow-up period of 11 months is reached, until death, until metastasectomy, until lost to follow-up or until (consent) withdrawal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Man or woman ≥ 18 years of age at the time the informed consent is obtained
- •Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- •Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease
- •At least 1 uni-dimensionally measurable lesion of at least 10 mm per RECIST 1.1 guidelines using conventional techniques (CT scan). Lesion must not be chosen from a previously irradiated field, unless there has been documented disease progression in that field after irradiation and prior to inclusion. All sites of disease must be evaluated <28 days prior to the start of first-line therapy
- •Wild-type RAS tumor status (of tumor tissue)
- •Wild-type BRAF tumor status (of tumor tissue)
- •Adequate hematologic, renal, hepatic and coagulation function
- •Starting a first-line treatment with a combination of FOLFOX/FOLFIRI and panitumumab
排除标准
- •History of prior or concurrent central nervous system metastases
- •History of other malignancy, except:
- •Malignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to start therapy and felt to be at low risk for recurrence by the treating physician
- •Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
- •Adequately treated cervical carcinoma in situ without evidence of disease
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic colorectal carcinoma including but not limited to bevacizumab and anti-Epidermal Growth Factor Receptor (EGFR) therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)
- •Prior adjuvant chemotherapy (including oxaliplatin therapy) or other adjuvant systemic anticancer therapy including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) for the treatment of colorectal cancer ≤ 6 months prior to start therapy with the following exceptions:
- •Subjects may have received prior fluoropyrimidine therapy if administered solely for the purpose of radiosensitization for the adjuvant or neoadjuvant treatment of rectal cancer
- •Radiotherapy ≤ 14 days prior to start therapy. Subjects must have recovered from all radiotherapy-related toxicities.
- •Significant cardiovascular risk
- •History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on diagnostic CT scan
- •Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as ≥ Common Terminology Criteria (CTC) grade 2, [Common Terminology Criteria for Adverse Events (CTCAE) version 5.0])
- •Peripheral sensory neuropathy (≥ CTC grade 2 [CTCAE version 5.0])
结局指标
主要结局
Optimize cutoff value
时间窗: Start cycle 1 of first-line FOLFOX/FOLFIRI and panitumumab therapy until the day on which the first CT scan is performed following the liquid biopsies taken 9 months after the start of first-line therapy, or when 11 months of follow-up is reached.
Optimization of the cutoff value for NPY methylation in liquid biopsies (ctDNA) in metastatic colorectal cancer patients receiving first-line FOLFOX/FOLFIRI and panitumumab to discriminate between progressive and non-progressive disease as determined by CT scans based on RECIST criteria 1.1. To this end, a Receiver Operating Characteristic (ROC) curve will be developed with data of this study.
次要结局
- Determine progression free and 9-month survival(Start cycle 1 of first-line FOLFOX/FOLFIRI and panitumumab therapy until the day on which the first CT scan is performed following the liquid biopsies taken 9 months after the start of first-line therapy, or when 11 months of follow-up is reached.)