Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer

• Sponsor: Klinik Favoriten (Other)
• Overall Status: Completed
• CT.gov ID: NCT05172635
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 80.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Neoplasm

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer
• Actual Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Feb 15, 2021
• Actual Study Completion Date: Feb 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Pathological response of the primary tumour [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 Outcome Measures

1. 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.]

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

2. Overall survival [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 [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 [90 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic Favoriten	Vienna	Vienna/Austria	Austria	1020

Sponsors and Collaborators

• Klinik Favoriten

Investigators

• Principal Investigator: Thomas Gruenberger, Prof. Dr. med., Clinic Favoriten (HPB center)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Gruenberger, Prim. Prof. Dr. med., Klinik Favoriten
• ClinicalTrials.gov Identifier: NCT05172635
• Other Study ID Numbers: 0001
• First Posted: Dec 29, 2021
• Last Update Posted: Dec 29, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Thomas Gruenberger, Prim. Prof. Dr. med., Klinik Favoriten: colorectal cancer; synchronous liver metastases; targeted therapy; tumour regression grading
• Additional relevant MeSH terms: Colorectal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasm Metastasis

Study Results

No Results Posted as of Dec 29, 2021