ANALYSIS OF EFFECTIVENESS OF NEOADJUVANT CHEMOTHERAPY IN THE TREATMENT OF LOCALLY ADVANCED COLON CANCER.
Key facts
- Where
- Badajoz, Burgos, Galdakao, León, Lugo, Madrid, Murcia, Oviedo, Palma, Pamplona, Salamanca, Talavera De La Reina, Valencia, Valladolid és Vigo, SpanyolországSee the 18 sites
- Phase
- 2. fázis
Where in Spanyolország
- Hospital Universitario de BadajozBadajoz, SpanyolországTaking people
- Hospital Universitario De BurgosBurgos, SpanyolországTaking people
- Hospital de Galdakao-UsansoloGaldakao, SpanyolországTaking people
- Hospital Universitario De LeonLeón, SpanyolországTaking people
- Hospital Universitario Lucus AugustiLugo, SpanyolországTaking people
- Clinica Universidad de NavarraMadrid, SpanyolországTaking people
- Hospital Central de la Defensa Gómez UllaMadrid, SpanyolországTaking people
- Hospital Universitario Infanta LeonorMadrid, SpanyolországTaking people
- Hospital Universitario La PazMadrid, SpanyolországTaking people
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpanyolországTaking people
- Hospital Universitario Central De AsturiasOviedo, SpanyolországTaking people
- Hospital Son LlatzerPalma, SpanyolországTaking people
- Clínica Universidad de navarraPamplona, SpanyolországTaking people
- Hospital Universitario De SalamancaSalamanca, SpanyolországTaking people
- Hospital Nuestra Senona Del PradoTalavera De La Reina, SpanyolországTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpanyolországTaking people
- Hospital Universitario Rio HortegaValladolid, SpanyolországTaking people
- Hospital Alvaro CunqueiroVigo, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Clinica Universidad De Navarra
- Trial code
- EU 2024-519825-39-00
- Record updated
- 2025. január 30.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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).
Exclusion: Significant comorbidity, uncontrolled angina or history of acute myocardial infarction in the last 6 months; Personal history of another neoplasm in the last 5 years, except for melanoma; Uncontrolled infection; Rectal cancer (< 15 cm from the anal verge or below the peritoneal reflection); 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; Pregnancy or breastfeeding; Peripheral neuropathy > grade 1; Presence of distant metastasis or peritoneal carcinomatosis; Intestinal obstruction; Existence of microsatellite instability.