2024-514294-22-01RecruitingPhase 3
Neoadjuvant chemotherapy versus standard treatment in patients with locally advanced colon cancer (NeoCol)
Lillebaelt Hospital7 sites in 2 countries247 target enrollmentStarted: September 27, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 247
- Locations
- 7
- Primary Endpoint
- Two-year disease free survival
Study Overview
Brief Summary
To investigate the effect of neoadjuvant chemotherapy in locally advanced colon cancer as estimated by disease free survival.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Histologically verified locally advanced T3 (ETI > 5 mm) or T4 colon cancer assessed by CT scan. • Age ≥ 18 years • PS 0-
- •Hematology ANC ≥1.5x109/l. Thrombocytes ≥ 100x109/l. • Biochemistry Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal value • Consent to translational research • Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment. • Written and orally informed consent.
Exclusion Criteria
- •Patients with distant metastases. • Acute operation • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before inclusion. • Active, serious infection or other serious disease. • Peripheral neuropathy NCI grade > 1 • Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri. • Other investigational treatment within 30 days prior to treatment start. • Hypersensitivity to one or more of the active or auxiliary substances.
Outcomes
Primary Outcomes
Two-year disease free survival
Two-year disease free survival
Secondary Outcomes
No secondary outcomes reported
Investigators
Lars Henrik Jensen
Scientific
Lillebaelt Hospital
Study Sites (7)
Loading locations...
Similar Trials
Recruiting
Phase 2
ANALYSIS OF EFFECTIVENESS OF NEOADJUVANT CHEMOTHERAPY IN THE TREATMENT OF LOCALLY ADVANCED COLON CANCER.2024-519825-39-00Clinica Universidad De Navarra238
Unknown
Phase 2
Analysis of the Effectiveness of Neoadjuvant Chemotherapy in the Treatment of Colon Cancer Locally Advanced (ELECLA)Locally Advanced Colon CancerNCT04188158Universidad de León238
Recruiting
Phase 3
A study of Chemo only versus Chemo plus Nivo with or without BMS986205, Followed by Post- Surgery Therapy with Nivo or Nivo and BMS986205 in Patients with MIBC2024-512158-12-00Bristol Myers Squibb International Corporation386
Recruiting
Phase 3
Chemotherapy in locally advanced colon cancerIRCT20130819014404N2Mashhad University of Medical Sciences58
Recruiting
Phase 2
Study of chemotherapy and immunotherapy for patients with lung cancer bounded in the thorax and potentially resectable2024-513731-24-00Fundacion GECP90