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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05322486
Other study ID # 22A/20
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 29, 2020
Est. completion date December 2022

Study information

Verified date April 2022
Source State Scientific Centre of Coloproctology, Russian Federation
Contact Iuliia Alimova, MD
Phone +7 (916) 868-80-25
Email doctoralimova@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Currently, the question remains whether palliative primary tumor resection could improve overall survival of minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases. The aim of this study is to determine if there is an improvement in overall survival of palliative primary tumor resection followed by chemotherapy in minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases compared to those of upfront chemotherapy/radiotherapy alone.


Description:

The present study is a single-center retrospective observational cohort study with a propensity score matching. Between 2016 and 2022 from our institutional database minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases will be selected. Patients will be divided into two groups: 1. Surgical resection of the primary tumour before to systemic therapy 2. Systemic therapy without previous resection of the primary tumour. Propensity score matching (PSM) will be performed, to minimize the selection bias by adjusting variables that may affect the survival of patients. Categorical variables will be compared using the chi-square test or Fisher's exact test. Continuous variables will be compared using the Student's t-test or Mann-Whitney U test. Survival rate will be determined by using Kaplan-Meier analysis with a log-rank test. Univariate and multivariate analyses for survival will be conducted using Cox proportional hazard models. Statistical results will be considered significant at p values less than 0.05.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Histologically confirmed colorectal adenocarcinoma 2. Resectable minimally symptomatic primary tumor with unresectable synchronous metastasis 3. Age = 18 years 4. Informed consent Exclusion Criteria: 1. Synchronous cancers 2. Carcinomatosis 3. Prior surgery, chemotherapy, radiation therapy for the primary tumor or distant metastases

Study Design


Intervention

Procedure:
surgery of the primary tumour
Surgical resection of the colon tumour, R0. No surgical intervention on metastasis.
Drug:
chemotherapy
Chemotherapy with or without biological drugs.

Locations

Country Name City State
Russian Federation Ryzhikh National Medical Research Center of Coloproctology Moscow

Sponsors (1)

Lead Sponsor Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival 3 years
Secondary Thirty-day mortality 30 days
Secondary Rate of surgical intervention due to complication of treatment 1 year
Secondary Progression free survival (PFS) PFS is defined as the time interval between the date of diagnosis and the first date of progression of the metastatic disease or death in both treatment arms. 3 years
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