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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Digestive System Diseases; Gastrointestinal Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasm Metastasis; Intestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Neoplasms, Second Primary; Colonic Disease
• Intervention / Treatment: Procedure: surgery of the primary tumour; Drug: chemotherapy

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Iuliia Alimova, MD; Phone Number: +7 (916) 868-80-25; Email: doctoralimova@gmail.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • Ryzhikh National Medical Research Center of Coloproctology
    • Contact: Iuliia Alimova, MD; Phone Number: +7 (916) 868-80-25; Email: doctoralimova@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary tumour resection group.; Surgical resection of the primary tumour followed by chemotherapy +/- targeted therapy regime.	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.
Chemotherapy group.; Chemotherapy +/- targeted therapy alone.	Drug: chemotherapy; Chemotherapy with or without biological drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thirty-day mortality		30 days
Rate of surgical intervention due to complication of treatment		1 year
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

Collaborators and Investigators

• Sponsor: State Scientific Centre of Coloproctology, Russian Federation

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 2, 2022
• First Submitted That Met QC Criteria: April 2, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal cancer; Chemotherapy; Unresectable metastases; Primary tumor resection; Minimally symptomatic primary tumor
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Intestinal Diseases; Intestinal Neoplasms; Neoplasms by Site; Neoplasms, Second Primary; Colonic Diseases; Rectal Diseases
• Other Study ID Numbers: 22A/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No