Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases
NCT ID: NCT05322486
Last Updated: 2022-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-10-29
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Primary tumour resection group.
Surgical resection of the primary tumour followed by chemotherapy +/- targeted therapy regime.
surgery of the primary tumour
Surgical resection of the colon tumour, R0. No surgical intervention on metastasis.
chemotherapy
Chemotherapy with or without biological drugs.
Chemotherapy group.
Chemotherapy +/- targeted therapy alone.
chemotherapy
Chemotherapy with or without biological drugs.
Interventions
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surgery of the primary tumour
Surgical resection of the colon tumour, R0. No surgical intervention on metastasis.
chemotherapy
Chemotherapy with or without biological drugs.
Eligibility Criteria
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Inclusion Criteria
2. Resectable minimally symptomatic primary tumor with unresectable synchronous metastasis
3. Age ≥ 18 years
4. Informed consent
Exclusion Criteria
2. Carcinomatosis
3. Prior surgery, chemotherapy, radiation therapy for the primary tumor or distant metastases
18 Years
ALL
No
Sponsors
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State Scientific Centre of Coloproctology, Russian Federation
OTHER_GOV
Responsible Party
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Locations
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Ryzhikh National Medical Research Center of Coloproctology
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22A/20
Identifier Type: -
Identifier Source: org_study_id
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