2024-519825-39-00招募中2 期
ANALYSIS OF EFFECTIVENESS OF NEOADJUVANT CHEMOTHERAPY IN THE TREATMENT OF LOCALLY ADVANCED COLON CANCER.
Clinica Universidad De Navarra17 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2025年1月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 238
- 试验地点
- 17
- 主要终点
- 2 years disease-free survival
研究概览
简要总结
To determine if the proposed treatment with neoadjuvant chemotherapy, surgery and complementary chemotherapy increases Disease-Free Survival (DFS) at 2 years postoperatively, compared to the standard treatment, surgery and complementary chemotherapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of colon adenocarcinoma.
- •Radiologically resectable disease.
- •Who are going to undergo elective surgery with curative intent (R0).
- •Patients of both sexes aged over 18 years.
- •Good general condition of the patient (Karnofsky>60% or ECOG<2).
- •Analysis at the time of inclusion with hemoglobin levels >10 g/dL; Leukocytes >3.0 109/L, Platelets > 100,000, Glomerular Filtration >50 ml/min and Total Bilirubin <25 micromol/l.
- •Absence of contraindication for chemotherapy.
- •Acceptance and signing of the Informed Consent.
- •Radiological signs, evaluated by CT, of T4 or T3 tumor infiltration >5 mm of transmural invasion.
- •With or without lymph node involvement by CT.
- •Without metastatic involvement in other organs (M0).
排除标准
- •Significant comorbidity, uncontrolled angina or history of acute myocardial infarction in the last 6 months.
- •Refusal to participate or give written consent
- •Inability, at the discretion of the researcher, to understand the purpose of the study or comply with its procedures.
- •Personal history of another neoplasm in the last 5 years, except for melanoma.
- •Uncontrolled infection
- •Pregnancy or breastfeeding.
- •Peripheral neuropathy > grade
- •Rectal cancer (< 15 cm from the anal verge or below the peritoneal reflection).
- •Presence of distant metastasis or peritoneal carcinomatosis.
- •Intestinal obstruction.
- •Existence of microsatellite instability
结局指标
主要结局
2 years disease-free survival
2 years disease-free survival
次要结局
- Toxicity, according to the CTCAE scale (Common Terminology Criteria for Adverse Events) version 4.0.
- Disease-free survival (DFS) and overall survival (OS) at 5 years after randomization
- Postoperative morbidity and mortality: Frequency and type of postoperative complications and transfusion requirements
- Presence of local or distant recurrence and its location.
- Degree of therapeutic completion in each of the groups.
- Accuracy of CT to adequately diagnose LACC in the control group, studying the correlation between the staging of the preoperative CT and that given by the pathological analysis
- Information provided by the restaging CT with the degree of regression at the pathological level: Sensitivity, Specificity, Positive/Negative Predictive Value will be calculated.
- Utility of the scales commonly used in the assessment of the pathological tumor response in rectal cancer to determine this response in colon cancer, after neoadjuvant treatment.
- In the group of patients over 70 years of age receiving neoadjuvant chemotherapy, whether the addition of oxaliplatin impacts the pathological response.
研究者
Jorge Arredondo Chaves
Scientific
Clinica Universidad De Navarra
研究点 (17)
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