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

NCT05322486 | Unknown

• 1 other identifier: 22A/20
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

  3 years

Secondary Outcomes (3)

• Thirty-day mortality

  30 days

• Rate of surgical intervention due to complication of treatment

  1 year

• Progression free survival (PFS)

  3 years

Study Arms (2)

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

surgery of the primary tumour PROCEDURE

Surgical resection of the colon tumour, R0. No surgical intervention on metastasis.

Primary tumour resection group.

chemotherapy DRUG

Chemotherapy with or without biological drugs.

Chemotherapy group.; Primary tumour resection group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• State Scientific Centre of Coloproctology, Russian Federation: lead

Study Sites (1)

Ryzhikh National Medical Research Center of Coloproctology

Moscow, Russia

RECRUITING

MeSH Terms

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 Diseases; Intestinal Diseases; Rectal Diseases

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Iuliia Alimova, MD

CONTACT

+7 (916) 868-80-25; doctoralimova@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 11, 2022
• Study Start: October 29, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

RU (1)