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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05172635
Other study ID # 0001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2014
Est. completion date February 15, 2021

Study information

Verified date December 2021
Source Klinik Favoriten
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We performed a retrospective data analysis of patients with synchronously metastasized colorectal cancer, comparing the histological response on the primary tumour to chemotherapy combined with either vascular endothelial growth factor (VEGF) or epidermal growth factor receptor (EGFR) inhibition.


Description:

We performed a retrospective analysis regarding the response of the primary tumour and the liver metastases of patients with colorectal carcinoma to an induction chemotherapy with antibody therapy, either with a VEGF antibody, or with an EGFR antibody. We investigated 100 Patients with synchronous metastatic colorectal carcinoma, who underwent hepatic resection in Clinic Landstraße or Clinic Favoriten between 2014 and 2021. We investigated the tumour response of the primary tumour, using Rödel score, which is a tumour regression score. We also investigated the tumour response of the liver metastases using Rubbia Brandt tumour regression score. The pathological response was assessed postoperatively in the surgical specimen. In order to ensure a uniform assessment, the pathologists in our HPB center assessed the histological specimens from both treatment locations prior to this analyses. The tumour response of the liver metastases was assessed twice: by radiological tumour assessment via computer tomography (CT) of the abdomen or magnetic resonance imaging (MRI) of the liver with RECIST criteria. Postoperative complications less than 90 days after liver resection were assessed and described according to the classification system by Dindo et al. Day of tumour recurrence and/or death was assessed. We also investigated the difference of recurrence free Survival (RFS) and Overall surcical (OS) between the patients, who received EGFR and the patients, who received VEGF antibody treatment.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 15, 2021
Est. primary completion date February 15, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - older than 18 years - synchronously hepatic metastasized patients with colorectal carcinoma - indication of surgical treatment Exclusion Criteria: - younger than 18 years - metachronously metastasized patients

Study Design


Locations

Country Name City State
Austria Clinic Favoriten Vienna Vienna/Austria

Sponsors (1)

Lead Sponsor Collaborator
Klinik Favoriten

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pathological response of the primary tumour Investigation of the tumour response of the primary tumor (colorectal carcinoma) using the Rödel Score (tumour regression score) Tumour regression was assessed in the surgical specimen 3 to 7 days after surgery.
Secondary Pathological response of the liver metastases Investigation of the tumour response of the liver metastases using Rubbia Brand score (Tumour regression score) and using radiological assessment Tumour regression was assessed in the surgical specimen 3 to 7 days after surgery. Radiological response was assessed in staging CT abdomen 2 to 4 weeks after induction chemotherapy.
Secondary Overall survival Difference of overall survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment median of 21 months (0 to 80)
Secondary Recurrece free survival Difference of recurrence free survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment median of 21 months (0-80)
Secondary 90 day mortality number of patients, who died less than 90 days after liver surgery 90 days
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