A Prospective Study Assessing Whether Immunoscore Colon Test Impacts the Choice of Adjuvant Chemotherapy, in a Multidisciplinary Meeting, for Treating Non-metastatic Colon Cancer Patients After Curative-intent Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- UNICANCER
- 试验地点
- 22
- 主要终点
- Modification rate of adjuvant therapeutic strategy
研究概览
简要总结
Immunoscore Colon Test (ICT) will be applied on tumor samples from curative surgery. In the Multidisciplinary Meeting (MM) evaluating the participant adjuvant strategy, a first decision will be taken, based on the participant medical record only. ICT will then be disclosed and the MM will take a second decision. The aim of the study is to observe if the ICT result modifies the treatment decision.
详细描述
On previous studies, Immunoscore Colon test identified subgroups of stage II and III colon cancer patients whose Chemotherapy could be adjusted.
The study hypothesis is that Immunoscore Colon Test will modify the therapeutic decision in MM.
With Alpha and Beta at 5% and p0=10% modification rate, the participating investigators need to include 280 participants, 140 in each cohort (stage II and stage III).
Participants will have tumor samples from their curative surgery tested with Immunoscore Colon. When the patients are evaluated in MM, a first therapeutic decision will be taken before disclosing the test result. ICT result will then be communicated and a second decision will be taken.
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
盲法说明
Immunoscore Colon Test Result will be disclosed in Multidisciplinary Meeting only after the first therapeutic decision
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
- •Cytologically/histologically proven colon adenocarcinoma
- •non-metastatic cancer
- •Stage II or III adenocarcinoma
- •Surgical resection of primitive tumor within 6 weeks of multidisciplinary meeting
- •No macroscopic or microscopic proof of residual disease during surgery (R0 margins)
- •Available surgical material: FFPE tumor samples
- •Post-operative adjuvant chemotherapy considered during multidisciplinary meeting
- •Age ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Patient having signed a written informed consent prior to any trial specific procedures
- •Patient affiliated to the social security system or equivalent
排除标准
- •Other invasive cancer within 5 years of the colon cancer diagnosis, except for adequately treated basal cell carcinoma or squamous cell skin carcinoma or in sity cervical carcinoma
- •Patients for which adjuvant chemotherapy is contra-indicated
- •Any previous systemic or loco regional anticancer therapy for the studied colon cancer (e.g. neoadjuvant therapy)
- •Patient enrolled or planned to be enrolled in another clinical trial that may influence the therapeutic decision
- •Any psychological, social or geographical issue that may hinder the patient's understanding of the study or the study conduct
- •Person deprived of liberty or under the authority of a legal guardian
- •Person unable to understand the study or to comply with the protocol procedures
研究组 & 干预措施
Single arm
All participants are included in the same arm. Immunoscore Colon Test is applied on a tumor sample and the result is kept secret. In the Multidisciplinary Meeting evaluating the adjuvant therapy of the participant, a first therapeutic decision is taken, then Immunoscore result will be disclosed and the Multidisciplinary Meeting will take a second decision.
干预措施: Immunoscore Colon Test (Diagnostic Test)
结局指标
主要结局
Modification rate of adjuvant therapeutic strategy
时间窗: At the multidisciplinary meeting, up to 6 weeks after the cancer surgery
Modifications of adjuvant therapy, type and/or duration
次要结局
未报告次要终点