Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer

NCT05172635 | Completed DMC

• 1 other identifier: 0001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Patients, who received a VEGF antibody

We distinguished between patients who received a VEGF antibody therapy and patients who received a EGFR antibody therapy.

Patients, who received a EGFR antibody

We distinguished between patients who received a VEGF antibody therapy and patients who received a EGFR antibody therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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..

You may qualify if:

• older than 18 years
• synchronously hepatic metastasized patients with colorectal carcinoma
• indication of surgical treatment

You may not qualify if:

• younger than 18 years
• metachronously metastasized patients

Sponsors & Collaborators

• Klinik Favoriten: lead

Study Sites (1)

Clinic Favoriten

Vienna, Vienna/Austria, 1020, Austria

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Thomas Gruenberger, Prof. Dr. med.

  Clinic Favoriten (HPB center)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prim. Prof. Dr. med.

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: December 29, 2021
• Study Start: June 1, 2014
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

AU (1)