Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Elaboration of a predictive model, based on biological and functional imaging parameters, for the response to monoclonal antibodies as assessed through RECIST criteria 2 months after the beginning of treatment
研究概览
简要总结
Primary Objective: This trial is elaborating a model for rapidly predicting (day 21) the response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and bevacizumab) based on biological markers and/or functional imaging. The response to treatment is evaluated by the conventional method after 2 months (Response Evaluation Criteria in Solid Tumors [RECIST] criteria).
Secondary Objectives:
- This trial is also analyzing the correlation between the magnitude of response to treatment at 2 months (stabilization or objective response, RECIST criteria) and that of response observed after 6 months of treatment.
- The organisational objective is to develop a tumour bank of metastatic colorectal cancer.
Population: The population includes 252 male and female patients with metastatic colorectal cancer justifying the use of cetuximab or bevacizumab, with no heart disease.
Techniques: Computed tomography (CT scan), functional imaging (ultrasound with SonoVue); molecular imaging (positron emission tomography [PET] with fluorodeoxyglucose F18 [18-FDG]); and biology and pathology on microbiopsy of liver metastasis are used.
Outcome Criteria: The primary outcome is response to treatment with monoclonal antibodies according to RECIST criteria at two months.
Studied Factors:
Radiology:
- CT scan: RECIST criteria (gold standard);
- Ultrasound with SonoVue injection: 1 representative target (delay of contrast appearance, peak of rising, curve of increase and decrease of the signal, area under the curve, time of average transit).
Nuclear Medicine: PET scan and 18-FDG (standard uptake values [SUV])
Molecular Characterization of Tumors: p53 status; microsatellite instability (MSI) status; expression of oncogenes; EGFR status; VEGF status; determination of FcgammaRIIIA polymorphisms
Statistics:
-
Descriptive analyses;
-
Analysis of the appropriate threshold to measure: response to treatment by an ultrasound with SonoVue and by PET scan; correlation between response predicted by the ultrasound with SonoVue and the PET; conventional morphological CT at 2 months
-
Analysis of prognostic factors:
-
Evaluation of the role of each prognostic factor (pathology and imaging) on response to treatment;
-
Multivariate analysis of prognostic factors;
-
Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >= 18 years old
- •Patients with colon or rectal carcinoma histologically proven
- •Patients with metastases (synchronous or metachronous)
- •Patients with associated extra-hepatic disease (asymptomatic primary tumor or extra-hepatic metastases)
- •Performance status (World Health Organization [WHO]) = 0, 1, or 2
- •Life expectancy >= 3 months
- •Patients with normal haematological, kidney, and liver parameters (PNN > 1.5 x 10^9/L, platelets > 100 10^9/L, total bilirubin <= 1.25 x upper limit of normal (ULN), ASAT/ALAT <= 5 x ULN, creatinaemia <= 135 µmol/L (1.5 mg/dL)
- •No cardiac or coronary insufficiency untreated
- •At least 4 weeks between surgery and study beginning
- •Patients can have a biopsy of the hepatic lesion identified by ultrasound.
- •Informed consent signed.
排除标准
- •Patients with symptomatic tumors (colon or rectal)
- •Patients with others tumors not cured
- •Patients who cannot be treated by 5-fluorouracil (5-FU) and/or irinotecan because of special medical conditions or other serious disease.
- •Patients who participated in another clinical trial since less than 30 days
- •Pregnancy or breast-feeding women
- •Patients who cannot be treated because of active infection or other serious disease.
研究组 & 干预措施
1
Bevacizumab
干预措施: bevacizumab (Drug)
2
Cetuximab
干预措施: cetuximab (Drug)
结局指标
主要结局
Elaboration of a predictive model, based on biological and functional imaging parameters, for the response to monoclonal antibodies as assessed through RECIST criteria 2 months after the beginning of treatment
时间窗: at 7 weeks
次要结局
- Correlation between the response at 2 months and that at 6 months of treatment (taking into account the therapeutic adjustments during the 6-month follow-up)(at 6 month)