Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases

• Conditions: Digestive System Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Second Primary; Intestinal Diseases; Gastrointestinal Neoplasms; Neoplasm Metastasis; Digestive System Diseases
• Interventions: Procedure: surgery of the primary tumour; Drug: chemotherapy

• Registration Number: NCT05322486
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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.

Study Timeline

• Study Start: 2020-10-29
• Status Verified: 2022-04
• Study First Submitted: 2022-04-02
• Study First Submitted QC: 2022-04-02
• Last Update Submitted: 2022-04-02
• Study First Posted: 2022-04-11
• Last Update Posted: 2022-04-11
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary tumour resection group.	surgery of the primary tumour	Surgical resection of the primary tumour followed by chemotherapy +/- targeted therapy regime.
Primary tumour resection group.	chemotherapy	Surgical resection of the primary tumour followed by chemotherapy +/- targeted therapy regime.
Chemotherapy group.	chemotherapy	Chemotherapy +/- targeted therapy alone.

Primary Outcome Measures

Name	Time	Method
Overall survival	3 years

Secondary Outcome Measures

Name	Time	Method
Thirty-day mortality	30 days
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.
Rate of surgical intervention due to complication of treatment	1 year

Trial Locations

Locations (1)

Ryzhikh National Medical Research Center of Coloproctology; 🇷🇺 Moscow, Russian Federation