Clinical trial · Interventional
Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis
BEV-IP: Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis
NCT02399410CI-TRIAL-00073381completedPhase 2ClinicalTrials.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 Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment consisting of perioperative combination chemotherapy with the vascular endothelial growth factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytoreductive surgery | Procedure | — | UNRESOLVED |
| Intraperitoneal Oxaliplatin | Drug | — | UNRESOLVED |
| perioperative chemotherapy plus bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bevacizumab and CRS with oxaliplatin
- description
- Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
- interventionNames
- Drug: perioperative chemotherapy plus bevacizumab
- Procedure: cytoreductive surgery
- Drug: Intraperitoneal Oxaliplatin
Primary outcomes (1)
- measure
- surgical morbidity and mortality
- timeFrame
- until 3 months after surgery and intraperitoneal chemotherapy
- description
- This will be estimated with the Dindo-Clavien classification
Secondary outcomes (5)
- measure
- progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * biopsy proven adenocarcinoma of the colon or rectum and synchronous or metachronous peritoneal carcinomatosis. * absence of systemic disease, with the exception of small, superficial liver metastases, requiring only minor surgery. * resectable disease at staging, during laparoscopic evaluation and during exploration for cytoreductive surgery and intraperitoneal chemotherapy. * complete macroscopic cytoreduction at the time of surgery (CC-0/1) * good general health status (Karnofsky index \> 70%) * expected life expectancy more than 6 months * no other malignancy than disease under study * serum creatinine \< 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m * serum total bilirubin \< 1.5 mg/dl * platelet count \> 100,000/ml * hemoglobin \> 9g/dl * neutrophil granulocytes \> 1,500/ml * International Normalized Ration (INR) 2 or \< 2 * Absence of alcohol and/or drug abuse * No inclusion in other clinical trials interfering with the study protocol * No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * Absence of heart failure (NYHA 2 or \> 2) or significant coronary artery disease * No pregnancy or breast feeding * Adequate contraception in fertile patients Exclusion Criteria: * No written informed consent * tumour in the presence of obstruction * evidence of extra-abdominal disease or extensive liver metastasis * peritoneal cancer index \> 25 * active bacterial, viral or fungal infection * active gastro-duodenal ulcer * parenchymal liver disease (any stage cirrhosis) * uncontrolled diabetes mellitus * severe obstructive or restrictive respiratory insufficiency * psychiatric pathology capable of affecting comprehension and judgment faculty * Known allergy to oxaliplatin
References
Publications (35)
- BACKGROUNDHerszenyi L, Tulassay Z. Epidemiology of gastrointestinal and liver tumors. Eur Rev Med Pharmacol Sci. 2010 Apr;14(4):249-58. PMID 20496531
- BACKGROUNDPeeters M, Price T. Biologic therapies in the metastatic colorectal cancer treatment continuum--applying current evidence to clinical practice. Cancer Treat Rev. 2012 Aug;38(5):397-406. doi: 10.1016/j.ctrv.2011.08.002. Epub 2011 Sep 6. PMID 21899955
- BACKGROUNDKlaver YL, Simkens LH, Lemmens VE, Koopman M, Teerenstra S, Bleichrodt RP, de Hingh IH, Punt CJ. Outcomes of colorectal cancer patients with peritoneal carcinomatosis treated with chemotherapy with and without targeted therapy. Eur J Surg Oncol. 2012 Jul;38(7):617-23. doi: 10.1016/j.ejso.2012.03.008. Epub 2012 May 8. PMID 22572106
- BACKGROUNDKoppe MJ, Boerman OC, Oyen WJ, Bleichrodt RP. Peritoneal carcinomatosis of colorectal origin: incidence and current treatment strategies. Ann Surg. 2006 Feb;243(2):212-22. doi: 10.1097/01.sla.0000197702.46394.16. PMID 16432354
- BACKGROUNDSegelman J, Granath F, Holm T, Machado M, Mahteme H, Martling A. Incidence, prevalence and risk factors for peritoneal carcinomatosis from colorectal cancer. Br J Surg. 2012 May;99(5):699-705. doi: 10.1002/bjs.8679. Epub 2012 Jan 27. PMID 22287157
- BACKGROUNDLemmens VE, Klaver YL, Verwaal VJ, Rutten HJ, Coebergh JW, de Hingh IH. Predictors and survival of synchronous peritoneal carcinomatosis of colorectal origin: a population-based study. Int J Cancer. 2011 Jun 1;128(11):2717-25. doi: 10.1002/ijc.25596. Epub 2010 Oct 13. PMID 20715167
- BACKGROUNDTran B, Kopetz S, Tie J, Gibbs P, Jiang ZQ, Lieu CH, Agarwal A, Maru DM, Sieber O, Desai J. Impact of BRAF mutation and microsatellite instability on the pattern of metastatic spread and prognosis in metastatic colorectal cancer. Cancer. 2011 Oct 15;117(20):4623-32. doi: 10.1002/cncr.26086. Epub 2011 Mar 31.