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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322486
• Other study ID #: 22A/20
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Colonic Disease
• Colonic Diseases
• Colorectal Neoplasms
• Digestive System Diseases
• Digestive System Neoplasms
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Intestinal Diseases
• Intestinal Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Neoplasms by Site
• Neoplasms, Second Primary
• Rectal Diseases

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