Clinical trial · Interventional
Colorectal Cancer (CRC) Cetuximab Elderly Frail
Treatment of Patients With KRAS Wild Type Advanced Colorectal Cancer (CRC) With 5-Fluorouracil (5-FU) or 5- FU Plus an Epidermal Growth Factor Receptor (EGFR) Inhibitor (Cetuximab) Based on a Comprehensive Geriatric Assessment (CGA).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
OBJECTIVE: The principal objective of the trial is to evaluate whether the addition of cetuximab associated with 5-fluorouracil in elderly patients with KRAS wild type advanced colorectal cancer (CRC) prolongs Progression Free Survival, compared with 5-fluorouracil alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| leucovorin | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 5-fluorouracil/leucovorin plus cetuximab
- interventionNames
- Drug: Cetuximab
- Drug: 5-fluorouracil
- Drug: leucovorin
- type
- ACTIVE_COMPARATOR
- label
- 5-fluorouracil/leucovorin alone
- interventionNames
- Drug: 5-fluorouracil
- Drug: leucovorin
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 19 months from first patient in
- description
- Progression will be defined according to the "RECIST V1.1"
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed metastatic colorectal cancer * Measurable disease according to RECIST V1.1 * Histological local review and analysis of KRAS * Age ≥ 80 or ≥ 70 in combination with functional restrictions defined as limitation in at least 2 of 8 IADL * WHO performance status 0, 1 or 2 * Adequate bone marrow reserves, hepatic function \& renal function * Normal 12 lead ECG without clinically significant abnormalities * Written informed consent before randomization according to ICH/EU GCP, and local, national and international regulations Exclusion Criteria: * Prior systemic chemotherapy for metastatic disease * Previous exposure to EGFR or VEGF/VEGFR targeted therapy * Patients may have received chemotherapy in the adjuvant or neoadjuvant setting (CRC). The treatment-free interval should be 6 months or more from the end of (neo-)adjuvant therapy * Previous radiotherapy, either in the adjuvant setting or for the treatment of bone metastases, is allowed provided that the measurable lesions are outside the radiation fields * Persistence of clinically relevant treatment-related toxicities from previous chemotherapy and/or radiotherapy (adjuvant or neo-adjuvant setting) * Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of treatment or concomitantly with this trial * Known alcohol or drug abuse * Clinically significant cardiovascular disease * Evidence of uncontrolled medical comorbidities despite adequate treatment * Patients who have suffered a cerebrovascular accident or transient ischemic attack within the past 12 months * History, within the past 5 years, of malignancies other than CRC * Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and followup schedule
References
Publications (0)
Data not yet available