Capecitabine for Locally advanced colon cancer

Inclusion criteria

• {"criterion_text":"- Histological confirmation of colon adenocarcinoma.\n- Patients of both sexes aged over 18 years.\n- Good general condition of the patient (Karnofsky>60% or ECOG<2).\n- 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.\n- Absence of contraindication for chemotherapy.\n- Acceptance and signing of the Informed Consent.\n- Radiological signs, evaluated by CT, of T4 or T3 tumor infiltration >5 mm of transmural invasion.\n- With or without lymph node involvement by CT.\n- Without metastatic involvement in other organs (M0).\n- Radiologically resectable disease.\n- Who are going to undergo elective surgery with curative intent (R0)."}

Exclusion criteria

• {"criterion_text":"- Significant comorbidity, uncontrolled angina or history of acute myocardial infarction in the last 6 months.\n- Personal history of another neoplasm in the last 5 years, except for melanoma.\n- Uncontrolled infection\n- Pregnancy or breastfeeding.\n- Peripheral neuropathy > grade 1.\n- Rectal cancer (< 15 cm from the anal verge or below the peritoneal reflection).\n- Presence of distant metastasis or peritoneal carcinomatosis.\n- Intestinal obstruction.\n- Existence of microsatellite instability\n- Refusal to participate or give written consent\n- Inability, at the discretion of the researcher, to understand the purpose of the study or comply with its procedures."}

Primary endpoints

• {"endpoint_text":"- 2 years disease-free survival","definition_or_measurement_approach":"Disease-free survival at 2 years postoperatively (DFS at 2 years after surgery)."}

Secondary endpoints

• {"endpoint_text":"- Disease-free survival (DFS) and overall survival (OS) at 5 years after randomization","definition_or_measurement_approach":"DFS and OS measured at 5 years after randomization."}
• {"endpoint_text":"- Postoperative morbidity and mortality: Frequency and type of postoperative complications and transfusion requirements","definition_or_measurement_approach":"Frequency and type of postoperative complications and transfusion requirements will be recorded and analysed."}
• {"endpoint_text":"- Presence of local or distant recurrence and its location.","definition_or_measurement_approach":"Documentation of local or distant recurrence and anatomical location."}
• {"endpoint_text":"- Toxicity, according to the CTCAE scale (Common Terminology Criteria for Adverse Events) version 4.0.","definition_or_measurement_approach":"Adverse events graded using CTCAE v4.0."}
• {"endpoint_text":"- Degree of therapeutic completion in each of the groups.","definition_or_measurement_approach":"Assessment of treatment completion rates per group."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Correlation between preoperative CT staging and pathological staging; accuracy metrics to be assessed."}
• {"endpoint_text":"- Information provided by the restaging CT with the degree of regression at the pathological level: Sensitivity, Specificity, Positive/Negative Predictive Value will be calculated.","definition_or_measurement_approach":"Sensitivity, specificity, positive and negative predictive values of restaging CT vs pathological regression will be calculated."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Validation of commonly used pathological response scales (from rectal cancer) to assess response in colon cancer after neoadjuvant treatment."}
• {"endpoint_text":"- In the group of patients over 70 years of age receiving neoadjuvant chemotherapy, whether the addition of oxaliplatin impacts the pathological response.","definition_or_measurement_approach":"Comparison of pathological response in patients >70 receiving neoadjuvant chemotherapy with or without oxaliplatin."}

Spain

Earliest CTIS Part Ii Submission Date

22-11-2024

Latest Decision Or Authorization Date

30-01-2025

Processing Time Days

69

Number Of Sites

18

Number Of Participants

238

Primary sponsor

Full Name

Clinica Universidad De Navarra

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain