2024-519825-39-00RecruitingPhase 2
ANALYSIS OF EFFECTIVENESS OF NEOADJUVANT CHEMOTHERAPY IN THE TREATMENT OF LOCALLY ADVANCED COLON CANCER.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 238 (estimated)
- First submitted
- 28 Jan 2025
- Start date
- 30 Jan 2025
- Lead sponsor
- Clinica Universidad De Navarra
- Diseases
- Colorectal cancer
- EU CT number
- 2024-519825-39-00
- EudraCT number
- 2016-002970-10
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 238
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with locally advanced colon cancer that can be removed by surgery and has not spread to other organs.
- Age
- Over 18 years
- Sex
- All sexes can join
- Disease stage
- Colon adenocarcinoma confirmed by tissue test. The tumor is T4, or T3 growing more than 5 mm through the bowel wall on CT. Lymph nodes may or may not be involved. No spread to other organs (M0). Surgery with the aim of removing all the cancer must be planned.
- Biomarker or test result
- People with microsatellite instability cannot join.
Main reasons for not taking part
- Rectal cancer
- Distant metastasis or cancer spread inside the abdominal lining
- Another cancer in the last 5 years, except melanoma
- Intestinal obstruction
- Pregnancy or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- 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
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Badajoz | Badajoz | Spain | Recruiting |
| Hospital Universitario De Burgos | Burgos | Spain | Recruiting |
| Hospital de Galdakao-Usansolo | Galdakao | Spain | Recruiting |
| Hospital Universitario De Leon | León | Spain | Recruiting |
| Hospital Universitario Lucus Augusti | Lugo | Spain | Recruiting |
| Hospital Universitario Infanta Leonor | Madrid | Spain | Recruiting |
| Clinica Universidad de Navarra | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
| Hospital Central de la Defensa Gómez Ulla | Madrid | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Recruiting |
| Hospital Universitario Central De Asturias | Oviedo | Spain | Recruiting |
| Hospital Son Llatzer | Palma | Spain | Recruiting |
| Clínica Universidad de navarra | Pamplona | Spain | Recruiting |
| Hospital Universitario De Salamanca | Salamanca | Spain | Recruiting |
| Hospital Nuestra Senona Del Prado | Talavera De La Reina | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Recruiting |
| Hospital Universitario Rio Hortega | Valladolid | Spain | Recruiting |
| Hospital Alvaro Cunqueiro | Vigo | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.