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ANALYSIS OF EFFECTIVENESS OF NEOADJUVANT CHEMOTHERAPY IN THE TREATMENT OF LOCALLY ADVANCED COLON CANCER.
EU CTIS ID: 2024-519825-39-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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).
- 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 1.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.