Gastrointestinal NeoplasmNCT05172635
Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer
An observational study of Gastrointestinal Neoplasm, run by Klinik Favoriten at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasm
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2014to 15 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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..
Who may be able to join
- older than 18 years
- synchronously hepatic metastasized patients with colorectal carcinoma
- indication of surgical treatment
Who cannot join
- younger than 18 years
- metachronously metastasized patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gastrointestinal Neoplasm
- Keywords
- colorectal cancer, synchronous liver metastases, targeted therapy, tumour regression grading
- Medical subject headings
- Gastrointestinal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response of the primary tumour
Investigation of the tumour response of the primary tumor (colorectal carcinoma) using the Rödel Score (tumour regression score)
Measured: Tumour regression was assessed in the surgical specimen 3 to 7 days after surgery.
Secondary outcomes (4)
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
Measured: 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
Difference of overall survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment
Measured: median of 21 months (0 to 80)
Recurrece free survival
Difference of recurrence free survival between patients, who received VEGF antibody treatment and patients, who received EGFR antibody treatment
Measured: median of 21 months (0-80)
90 day mortality
number of patients, who died less than 90 days after liver surgery
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Jun 2014
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Favoriten
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Gruenberger, Klinik Favoriten
- Investigators
- Thomas Gruenberger, Prof. Dr. med., Principal investigator, Clinic Favoriten (HPB center)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172635
- Sponsor's protocol ID
- 0001
- Status last verified
- Dec 2021
- First submitted
- 28 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05172635
- Acronym / sponsor ID
- 0001
- Conditions
- Gastrointestinal Neoplasm
- Keywords
- colorectal cancer, synchronous liver metastases, targeted therapy, tumour regression grading
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Klinik FavoritenUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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..
Key inclusion criteria (3 listed)
- older than 18 years
- synchronously hepatic metastasized patients with colorectal carcinoma
- indication of surgical treatment
Key exclusion criteria (2 listed)
- younger than 18 years
- metachronously metastasized patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
4 secondary outcomes
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.
Overall survival
Time frame: median of 21 months (0 to 80)
Recurrece free survival
Time frame: median of 21 months (0-80)
90 day mortality
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Gruenberger, Prof. Dr. med. principal investigator
Clinic Favoriten (HPB center)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Neoplasm, run by Klinik Favoriten at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response of the primary tumour (time frame: Tumour regression was assessed in the surgical specimen 3 to 7 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.