Clinical trial NCT05322486: Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases
Official title: Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases Versus Chemotherapy Alone
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Keywords: Colorectal cancer
Primary tumor resection
Minimally symptomatic primary tumor
Unresectable metastases
Chemotherapy
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2022-04-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with colorectal cancer and synchronous unresectable metastases between 2016 and 2022 from our institutional database.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Thirty-day mortality
timeFrame: 30 days
measure: Rate of surgical intervention due to complication of treatment
timeFrame: 1 year
measure: Progression free survival (PFS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Ryzhikh National Medical Research Center of Coloproctology
Study officials:
References: