Clinical trial · Observational
Prospective Observational Study of 1st and 2nd Line Vectibix® Use in RAS-wt mCRC Pts to Evaluate Pattern of Use and ORR
A Prospective Observational Study of 1st and 2nd Line Vectibix® Use in KRAS/NRAS-wt mCRC Patients to Evaluate Pattern of Use and Overall Response Rates
NCT02322736CI-TRIAL-00041590VISIONcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will shed additional light on the impact of Vectibix® under the current, standard clinical conditions of mCRC treatment in Greece. It will provide data on the duration and the outcomes of Vectibix® treatment in real-life setting.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- WT RAS mCRC
- description
- Wild Type RAS metastatic colorectal cancer patients
Primary outcomes (1)
- measure
- To describe the pattern of use of Vectibix® in combination with chemotherapy in 1st line or in 2nd line mCRC treatments as per approved Vectibix® indication.
- timeFrame
- 42 months
- description
- Treatment patterns of Vectibix® and concomitant chemotherapy for mCRC will be decribed according to the following information: * Type of chemotherapy combined with Vectibix® * Starting dose and dose administration schedule of Vectibix® and chemotherapy * Cumulative dose, maximum dose, duration of exposure and total number of infusions received from the initiation of Vectibix® therapy and chemotherapy * Dose alterations for Vectibix and chemotherapy (including changes in frequency, reductions and/or delays).
Secondary outcomes (1)
- measure
- To investigate the rate of objective response (ORR, defined as either a Complete Response or a Partial Response) and the rate of stable disease as best response in 1st line or in 2nd line chemotherapy regimens of mCRC including Vectibix®.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patient (age ≥18 years) at enrollment * Histological documentation of mCRC diagnosis * RAS WT tumor documented before study enrolment as per routine laboratory finding * Subjects whose care will be managed primarily by the enrolling physician and/or all records will be available * Measurable disease at baseline (preferably according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) if routinely used) * Currently under (begin up to 8 weeks before informed consent) a 1st or 2nd line treatment regimen, including Vectibix® as per indication * Tumor assessment (i.e. CT/MRI) within 16 weeks prior to first Vectibix® infusion * Signed informed consent Exclusion Criteria: * Participation in any interventional clinical study (currently or during the three previous months from enrollment). * Compromised ability to give informed consent (defined per clinical judgment). * Unknown or mutant RAS tumor type
References
Publications (0)
Data not yet available
No reference posted for this study.