Clinical trial · Observational
An Observational Study of Continued Bevacizumab Plus Chemotherapy Until First Progression in Participants With Metastatic Colorectal Cancer (CRC)
Hungarian Multicenter Non-Interventional Study of Continued Avastin (Bevacizumab) Plus Chemotherapy Until First Progression Following Induction Treatment With Chemotherapy Doublet Plus Avastin in First Line Treatment of Patients With Metastatic Colorectal Carcinoma
- 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)
This prospective, multicenter, observational study will investigate the effectiveness and safety of bevacizumab in routine clinical practice in participants with metastatic CRC. Participants are to have initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to the bevacizumab Summary of Product Characteristics (SmPC).
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 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Other | — | UNRESOLVED |
| Chemotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with CRC
- description
- This is an observational study; thus, no intervention or treatment is required by the protocol. During the study, the treatment will be determined according to the treating physician decision. Eligible participants will be observed for safety and efficacy of continued bevacizumab plus fluoropyrimidine-based doublet chemotherapy treatment in routine clinical practice for 1 year.
- interventionNames
- Other: Bevacizumab
- Combination Product: Chemotherapy
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From enrollment to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months)
Secondary outcomes (7)
- measure
- PFS on First-Line Therapy
- timeFrame
- From first dose of bevacizumab first-line treatment up to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with histologically confirmed CRC with metastatic lesion * Participants having initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to bevacizumab SmPC * Participants who previously received a minimum 9 cycles of 5-FU-based or a minimum 6 cycles of capecitabine-based induction doublet chemotherapy (i.e. 5-FU or capecitabine + oxaliplatin or irinotecan) plus bevacizumab * Disease evaluation showed stable disease, partial response, or complete response according to RECIST within one month Exclusion Criteria: * Contraindication to receive bevacizumab according to the bevacizumab SmPC * Participants who received more than 10 cycles of 5-FU-based or more than 7 cycles of capecitabine-based induction doublet chemotherapy plus bevacizumab * Pregnant or lactating women
References
Publications (0)
Data not yet available