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Clinical Trials/NCT05172635
NCT05172635CompletedNot Applicable

Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer

Klinik Favoriten1 site in 1 country100 target enrollmentStarted: June 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Pathological response of the primary tumour

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Pathological response of the primary tumour

Time Frame: Tumour 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 Outcomes

  • Pathological response of the liver metastases(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.)
  • Overall survival(median of 21 months (0 to 80))
  • Recurrece free survival(median of 21 months (0-80))
  • 90 day mortality(90 days)

Investigators

Sponsor
Klinik Favoriten
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas Gruenberger

Prim. Prof. Dr. med.

Klinik Favoriten

Study Sites (1)

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