Clinical trial NCT05172635: Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer
Official title: Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Neoplasm
Keywords: colorectal cancer
synchronous liver metastases
targeted therapy
tumour regression grading
Lead sponsor: Klinik Favoriten
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients had synchronously metastasized colorectal cancer and received surgical treatment because of their liver metastases in either Clinic Landstrasse or Clinic Favoriten (HPB center) in Vienna from June 2014 to February 2021..

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pathological response of the primary tumour
timeFrame: Tumour regression was assessed in the surgical specimen 3 to 7 days after surgery.
Secondary outcomes:
measure: Pathological response of the liver metastases
timeFrame: 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.
measure: Overall survival
timeFrame: median of 21 months (0 to 80)
measure: Recurrece free survival
timeFrame: median of 21 months (0-80)
measure: 90 day mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Clinic Favoriten
state: Vienna/Austria
Study officials:
affiliation: Clinic Favoriten (HPB center)
name: Thomas Gruenberger, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: