Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Neoplasms, Second Primary, Neoplasm Metastasis, Digestive System Diseases, Gastrointestinal Diseases, Colonic Disease, Intestinal Diseases, Rectal Diseases
Conditions
Keywords
Colorectal cancer, Primary tumor resection, Minimally symptomatic primary tumor, Unresectable metastases, Chemotherapy
Brief 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.
Detailed 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.
Interventions
PROCEDUREsurgery of the primary tumour
Surgical resection of the colon tumour, R0. No surgical intervention on metastasis.
DRUGchemotherapy
Chemotherapy with or without biological drugs.
Sponsors
State Scientific Centre of Coloproctology, Russian Federation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thirty-day mortality | 30 days | — |
| Rate of surgical intervention due to complication of treatment | 1 year | — |
| Progression free survival (PFS) | 3 years | 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. |
Countries
Russia
Contacts
Primary ContactIuliia Alimova, MD
Outcome results
None listed