Gastrointestinal Neoplasm Clinical Trial
Official title:
Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer
NCT number | NCT05172635 |
Other study ID # | 0001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2014 |
Est. completion date | February 15, 2021 |
Verified date | December 2021 |
Source | Klinik Favoriten |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | February 15, 2021 |
Est. primary completion date | February 15, 2021 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Clinic Favoriten | Vienna | Vienna/Austria |
Lead Sponsor | Collaborator |
---|---|
Klinik Favoriten |
Austria,
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 |
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