NCT01591590已完成不适用
Correlating the Tumoral Metabolic Progression Index Measured by Serial FDG PET-CT and Apparent Diffusion Coefficient Measured by MRI to Patient's Outcome in Advanced Colorectal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
The purpose of this study is to assess whether in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.
详细描述
Natural history of tumors is a poorly studied subject, the clinical evidence of some tumors aggressiveness as opposed to some other's indolent behavior has never been formally assessed in daily practice or in clinical studies and remains largely unpredictable. The patient's populations are in fact a mix between different tumoral phenotypes that while carrying the same apparent disease evolve with different outcomes.
We hypothesize that,in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.
If the hypothesis is verified, this finding could:
- Allow to define therapeutic strategies according to the tumoral metabolic progression index.
- Limit the need for randomization in the early drug development phases as each patient could be considered as his own control.
- To stratify patients according to their baseline metabolic growth rate in randomized controlled trials with overall survival as an endpoint.
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
- •Participants must have histologically confirmed colorectal cancer that is metastatic or unresectable and for which standard treatments do not exist or are no longer effective.
- •The tumor should be refractory to all standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and anti-EGFR monoclonal antibodies in case of wild type Kras (cetuximab or panitumumab) administered before study entry. Prior treatment with bevacizumab, regorafenib and/or aflibercept is allowed but not mandatory
- •Participants should be candidate for a Phase I study
- •Age equal or over 18 years.
- •Life expectancy of greater than 12 weeks.
- •ECOG performance status ≤
- •Participants must have normal organ and marrow function as defined below:
- •Total bilirubin within 2 × normal institutional upper limits AST/ALT/Alk Phosphatase levels < 5 × normal institutional upper limits Creatinine within 2 × normal institutional upper limits or creatinine clearance > 35mL/min
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry during the assessment. For women of childbearing potential a pregnancy test (urinary or serum) must be performed within 7 days prior to inclusion and it must be negative. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately within one month.
- •Signed written informed consent obtained prior to any study specific screening procedures).
排除标准
- •Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
- •Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
- •Participants who have had a major surgery or radiotherapy within 4 weeks prior to entering the study.
- •Patients receiving any experimental agents during the assessment time period.
- •Patients with uncontrolled brain metastases.
- •Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
- •Participants who have had a major surgery or radiotherapy within 4 weeks prior to entering the study
- •Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or any significant disease which, in the investigator's opinion, would exclude the patient from the study.
- •Pregnancy or breastfeeding before the FDG PET-CT scan examinations
- •Uncontrolled Diabetes.
- •Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
- •Contra-indications to the use of MRI: cardiac stimulator, implanted cardiac wires, any implanted electronic devices, intra-ocular metallic foreign bodies.
- •Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent.
结局指标
主要结局
Mortality
时间窗: 12 months
次要结局
- Tumour Progression(6 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Aerobic Capacity and Body Composition in Colon Cancer PatientsColonic NeoplasmsNCT00470782AHS Cancer Control Alberta40
进行中（未招募）
1 期
The change in PET and MRI measurements over time as a predictor for metastatic colorectal cancer outcome.Advanced colorectal cancer, refractory to all available medicationsMedDRA version: 18.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-006280-21-BEJules Bordet Institute53
已完成
不适用
Metabolomic analysis of colorectal cancer patients.Colorectal cancerJPRN-UMIN000018609ational cancer center hospital1,350
已完成
2 期
Biomarker analysis in advanced colorectal cancer patients treated with mFOLFOX6 plus bevacizumab or XELOX plus bevacizumabJPRN-UMIN000012442West Japan Oncology Group100
已完成
不适用
Colomid: Midkine as a predictive marker in colorectal cancerACTRN12613000111774Calvary Mater Newcastle Hospital33