Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer

Gastrointestinal Neoplasm Clinical Trial

Official title:

Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05172635
• Other study ID #: 0001
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Digestive System Neoplasms
• Gastrointestinal Neoplasm
• Gastrointestinal Neoplasms
• Neoplasm Metastasis

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