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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: surgery of the primary tumour
* Drug: chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary tumour resection group.<br>Surgical resection of the primary tumour followed by chemotherapy +/- targeted therapy regime. | Procedure: surgery of the primary tumour<br>* Surgical resection of the colon tumour, R0. No surgical intervention on metastasis.<br>Drug: chemotherapy<br>* Chemotherapy with or without biological drugs.<br>|
| Chemotherapy group.<br>Chemotherapy +/- targeted therapy alone. | Drug: chemotherapy<br>* Chemotherapy with or without biological drugs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Primary tumor resection, Minimally symptomatic primary tumor, Unresectable metastases, Chemotherapy