Clinical trial · Interventional
Exploration of Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab
Exploration of New Biologic Factors' Predictive Value , Especially Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab
- 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)
It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess the predictive value of VE-cadherin on the objective tumor response. Biological factors will be correlated to clinical outcome measures. 100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be enrolled. Patients will be followed every 10 weeks until progression in spite of bevacizumab or until they stop bevacizumab because of toxicity. Bevacizumab will be administered according to investigators appreciation. Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.
Conditions
Conditions (2)
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 |
| Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab + blood samples | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab + blood samples
- interventionNames
- Biological: Bevacizumab + blood samples
Primary outcomes (1)
- measure
- Response rate to treatment
- timeFrame
- Up to 1 year at most
- description
- A 30% response rate (complete or partial response) to treatment is expected. The response will be assessed according to RECIST criteria. This primary outcome measure is defined by the observation of at least one objective response during the treatment. This outcome measure will be correlated to biological factors.
Secondary outcomes (5)
- measure
- Clinical benefit
- timeFrame
- At progression or up to 1 year at most
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with a metastatic colorectal cancer proved histologically and treated with bevacizumab in first line. * At least one extra-osseous, non-irradiated, measurable site (\>= 10 mm with spiral CT). * No prior radiotherapy treatment unless treatment is over for at least 4 weeks. * Adult patients. * PS \<= 2. * Life expectancy greater than 3 months. * Mandatory affiliation with a healthy security insurance. * Signed written informed consent. Exclusion Criteria: * Prior chemotherapy for the metastatic cancer. * Prior bevacizumab treatment. * Other current cancer or previous cancer detected in the last 5 years that can be linked to the current disease. * Patient deprived of freedom. * Pregnant or lactating women.
References
Publications (18)
- BACKGROUNDBouvier AM, Remontet L, Jougla E, Launoy G, Grosclaude P, Buemi A, Tretarre B, Velten M, Dancourt V, Menegoz F, Guizard AV, Mace Lesec'h J, Peng J, Bercelli P, Arveux P, Esteve J, Faivre J. Incidence of gastrointestinal cancers in France. Gastroenterol Clin Biol. 2004 Oct;28(10 Pt 1):877-81. doi: 10.1016/s0399-8320(04)95152-4. PMID 15523225
- BACKGROUNDWeitz J, Koch M, Debus J, Hohler T, Galle PR, Buchler MW. Colorectal cancer. Lancet. 2005 Jan 8-14;365(9454):153-65. doi: 10.1016/S0140-6736(05)17706-X. PMID 15639298
- BACKGROUNDKozloff M, Yood MU, Berlin J, Flynn PJ, Kabbinavar FF, Purdie DM, Ashby MA, Dong W, Sugrue MM, Grothey A; Investigators of the BRiTE study. Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer: the BRiTE observational cohort study. Oncologist. 2009 Sep;14(9):862-70. doi: 10.1634/theoncologist.2009-0071. Epub 2009 Sep 2. PMID 19726453
- BACKGROUNDVan Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019. PMID 19339720
- BACKGROUNDGruenberger B, Tamandl D, Schueller J, Scheithauer W, Zielinski C, Herbst F, Gruenberger T. Bevacizumab, capecitabine, and oxaliplatin as neoadjuvant therapy for patients with potentially curable metastatic colorectal cancer. J Clin Oncol. 2008 Apr 10;26(11):1830-5. doi: 10.1200/JCO.2007.13.7679. PMID 18398148
- BACKGROUNDKabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol. 2005 Jun 1;23(16):3706-12. doi: 10.1200/JCO.2005.00.232. Epub 2005 May 2.