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临床试验/NCT05531045
NCT05531045尚未招募不适用

18F-FDG Positron Emission Tomography/Tomodensitometry for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
222
试验地点
1
主要终点
early metabolic response assessed by PERCIST criteria

研究概览

简要总结

The metastatic colo-rectal cancer (especially with hepatic metastatic lesions, but also peritoneal or pulmonary lesions) is a major public health issue, because of its frequency, the heavy treatments and the cost of new therapeutic molecules involved, in particular targeted therapies that can result in specific adverse events. The first-line treatment often consists of a polychemotherapy, which can be associated to a targeted therapy. According to the therapeutic response, patient condition and disease extent, some patients may benefit from prognosis-changing treatments such as surgery of metastases. However, the best morphological response is most of time evidenced after only 6 or 8 cycles of treatment, corresponding to 3 to 4 months. Therapeutic evaluation with FDG PET/CT is validated in several neoplasia (lymphoma, breast cancer). Data on FDG PET evaluation of colic cancer chemotherapy are currently insufficient to propose its use in the usual clinical setting. We thus are going to study the performance of early FDG PET therapeutic evaluation to predict response to first-line chemotherapy in patients with potentially resectable metastases. If early PET diagnostic performances prove satisfying, this approach could become of paramount importance to tailor therapeutic strategy for these patients, with the possibility of early modification of chemotherapy protocol, which is now possible thanks to the existence of therapeutic alternatives (chemotherapy intensification, replacement of oxaliptaine by irinotecan or conversely, replacement of an anti-EGFR by an anti-angiogenic or conversely).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically proved colo-rectal cancer
  • Measurable metastatic disease according to RECIST 1.1 criteria
  • Metastases considered potentially resectable (for example : hepatic, nodular peritoneal, lung lesions...) by the multidisciplinary committee meeting
  • Patient candidate to a first-line chemotherapy± targeted therapy according to standard protocols : LV5FU2, FOLFOX, FOLFIRI, FOLFIRINOX +/- bévacizumab, aflibercept , cétuximab, panitumumab
  • In case of metachrone metastasis, adjuvant chemotherapy stopped for more than 6 months before relapse diagnosis
  • Predictable life expectancy of more than 6 months
  • Signed informed consent
  • Age > 18 years

排除标准

  • Patient with another evolutive neoplastic disease
  • Patient participating in another study evaluating an imaging technique using ionizing radiations
  • Brain metastasis
  • Absence of health insurance coverage
  • Pregnant of breastfeeding woman
  • Hypersensitivity to FDG or to one of the excipients of used specialty

结局指标

主要结局

early metabolic response assessed by PERCIST criteria

时间窗: 4 months

次要结局

  • percentage of cases where early metabolic response evaluation would have led to a modification of the therapeutic strategy/management(Month 2)
  • Overall Survival(36 months)
  • ΔTLG between Pre-therapeutic and 2 cycles PET assessment(2 months)
  • Progression Free Survival(36 months)
  • ΔSUVmax (EORTC criteria) between Pre-therapeutic and 2 cycles PET assessment(2 months)
  • Resection of metastases defined by a R0 or R1 resection (macroscopically complete surgery with disease-free margins or minimal residual disease) after the end of first line chemotherapy(at the end of first line chemotherapy, an average of 12 months)
  • Best morphological response during the course of first line chemotherapy(at the end of first line chemotherapy, an average of 12 months)
  • ΔSULpeak (PERCIST criteria) between Pre-therapeutic and 2 cycles PET assessment(2 months)
  • ΔMTV between Pre-therapeutic and 2 cycles PET assessment(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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