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Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer

Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05172635
Enrollment
100
Registered
2021-12-29
Start date
2014-06-01
Completion date
2021-02-15
Last updated
2021-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Neoplasm

Keywords

colorectal cancer, synchronous liver metastases, targeted therapy, tumour regression grading

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Klinik Favoriten
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Pathological response of the primary tumourTumour regression was assessed in the surgical specimen 3 to 7 days after surgery.Investigation of the tumour response of the primary tumor (colorectal carcinoma) using the Rödel Score (tumour regression score)

Secondary

MeasureTime frameDescription
Pathological response of the liver metastasesTumour 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.Investigation of the tumour response of the liver metastases using Rubbia Brand score (Tumour regression score) and using radiological assessment
Overall survivalmedian of 21 months (0 to 80)Difference of overall survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment
Recurrece free survivalmedian of 21 months (0-80)Difference of recurrence free survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment
90 day mortality90 daysnumber of patients, who died less than 90 days after liver surgery

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026