Palliative Primary Tumor Resection in Minimally Symptomat... | NCT05322486

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

NCT05322486

Sponsor

State Scientific Centre of Coloproctology, Russian Federation

Status

Unknown status

Last Update Posted

Apr 11, 2022Actual

Enrollment

200Estimated

Phase

Not provided

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

Interventions

surgery of the primary tumour
chemotherapy

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2020Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Apr 2, 2022

First Submission Date that Met QC Criteria

Apr 2, 2022

First Posted Date

Apr 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2022

Last Update Posted Date

Apr 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Surgical resection of the primary tumour before to systemic therapy
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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Primary tumour resection group.		Surgical resection of the primary tumour followed by chemotherapy +/- targeted therapy regime.	Procedure: surgery of the primary tumour Drug: chemotherapy
Chemotherapy group.		Chemotherapy +/- targeted therapy alone.	Drug: chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery of the primary tumour	Procedure	Surgical resection of the colon tumour, R0. No surgical intervention on metastasis.	Primary tumour resection group.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival		3 years

Secondary Outcomes

Measure	Description	Time Frame
Thirty-day mortality		30 days
Rate of surgical intervention due to complication of treatment		1 year
Progression free survival (PFS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed colorectal adenocarcinoma
Resectable minimally symptomatic primary tumor with unresectable synchronous metastasis
Age ≥ 18 years
Informed consent

Exclusion Criteria:

Synchronous cancers
Carcinomatosis
Prior surgery, chemotherapy, radiation therapy for the primary tumor or distant metastases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who were diagnosed with colorectal cancer and synchronous unresectable metastases between 2016 and 2022 from our institutional database.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Iuliia Alimova, MD	Contact	+7 (916) 868-80-25		doctoralimova@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ryzhikh National Medical Research Center of Coloproctology	Recruiting	Moscow			Russia

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D016609	Neoplasms, Second Primary
D009362	Neoplasm Metastasis
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms