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Completed

NCT Number: NCT05172635

Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic Favoriten

Vienna, Vienna/Austria, 1020, Austria

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Pathological response of the liver metastases

    Time frame: 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.

    Investigation of the tumour response of the liver metastases using Rubbia Brand score (Tumour regression score) and using radiological assessment

  2. Overall survival

    Time frame: median of 21 months (0 to 80)

    Difference of overall survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment

  3. Recurrece free survival

    Time frame: median of 21 months (0-80)

    Difference of recurrence free survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment

  4. 90 day mortality

    Time frame: 90 days

    number of patients, who died less than 90 days after liver surgery

Sponsors and collaborators

Lead sponsor

Klinik Favoriten

Other

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2021
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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