Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Colonic Diseases

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Neoplasms, Second Primary

Digestive System Neoplasms

Rectal Diseases

Neoplastic Processes

Herbal and Botanical

All Drugs and Chemicals

Cola

Surgical resection of the primary tumour followed by chemotherapy +/- targeted therapy regime.

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

surgery of the primary tumour

Chemotherapy with or without biological drugs.

chemotherapy

Iuliia Alimova, MD

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.

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.

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

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

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.

State Scientific Centre of Coloproctology, Russian Federation

Antineoplastic Agents

Oxaliplatin

Bevacizumab

Fluorouracil

Irinotecan

Capecitabine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

First-line fluoropyrimidine-based chemotherapy with bevacizumab initiated within 4 weeks of randomization, followed by salvage therapy upon progression at the discretion of the local investigator. Surgery of primary tumour will be performed only when indicated by local signs or symptoms.

Surgery within 4 weeks of randomization followed by fluoropyrimidine-based chemotherapy with bevacizumab until progression or unacceptable toxicity, followed by salvage therapy upon progression at the discretion of the local investigator

Surgery of the primary tumour

First line fluoropyrimidine-based chemotherapy with bevacizumab. The chemotherapy regimen is to the discretion of the local investigator, who may choose between:

5FU/LV or capecitabine or capecitabine + oxaliplatin(CAPOX)or 5FU + oxaliplatin(FOLFOX 4 or FOLFOX 7)or 5FU + irinotecan (FOLFIRI) or capecitabine + irinotecan(CAPIRI)

Systemic treatment

M. Koopman, Prof MD PhD

H. JW de Wilt, Prof MD PhD

The clinical benefit of resection of the primary tumour in patients with synchronous unresectable metastases is not known. In the literature studies usually describe retrospective selected patients with synchronous metastases treated with or without resection of the primary tumour. All these studies are biased in patient selection and there are no prospective randomized studies on this topic. In patients with few or absent symptoms of the primary tumour, arguments both in favour and against initial resection have been presented, and therefore a randomized trial is warranted. Although recent publications suggest that resection of the primary tumour in synchronous metastasized colon cancer patients might not be necessary, this appears to be based on feasibility and not on clinical outcome. Several studies comparing large groups of patients with or without resection of the primary tumour suggest an improved survival when the primary tumour is resected. A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour during chemotherapy treatment or during later stages of the disease. A recent analysis of the CAIRO and CAIRO2 data showed that metastatic colon cancer patients who had a resection of the primary tumour prior to study entry, had an improved survival compared to patients without a resection of the primary tumour. However, these patients were selected after the primary tumour was resected and therefore these results are not corrected for surgical morbidity and mortality. The investigators here propose a randomized trial in order to demonstrate that resection of the primary tumour does improve overall survival.

The Role of Surgery of the Primary Tumour in Patients With Synchronous Unresectable Metastases of Colorectal Cancer

The Role of Surgery of the Primary Tumour With Few or Absent Symptoms in Patients With Synchronous Unresectable Metastases of Colorectal Cancer, a Randomized Phase III Study. A Study of the Dutch Colorectal Cancer Group (DCCG)

Overall survival of the intent-to-treat population

Adverse events grade 3-4 according to NCI-CTC 4.0

Number of patients requiring resection of the primary tumour in the non-resection arm

Having received at least one cycle of systemic treatment in arm A and surgery in arm B

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases	NCT05322486	Colorectal Neop... Intestinal Neop... Gastrointestina... Digestive Syste... Neoplasms by Si... Neoplasms Neoplasms, Seco... Neoplasm Metast... Digestive Syste... Gastrointestina... Colonic Disease Intestinal Dise... Rectal Diseases	surgery of the ... chemotherapy	18 Years -	State Scientific Centre of Coloproctology, Russian Federation
The Role of Surgery of the Primary Tumour in Patients With Synchronous Unresectable Metastases of Colorectal Cancer	NCT01606098	Colon Cancer Primary Tumour Rectal Cancer	Surgery of the ... Systemic treatm...	18 Years -	Dutch Colorectal Cancer Group
Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases	NCT05322486	Colorectal Neop... Intestinal Neop... Gastrointestina... Digestive Syste... Neoplasms by Si... Neoplasms Neoplasms, Seco... Neoplasm Metast... Digestive Syste... Gastrointestina... Colonic Disease Intestinal Dise... Rectal Diseases	surgery of the ... chemotherapy	18 Years -	State Scientific Centre of Coloproctology, Russian Federation
The Role of Surgery of the Primary Tumour in Patients With Synchronous Unresectable Metastases of Colorectal Cancer	NCT01606098	Colon Cancer Primary Tumour Rectal Cancer	Surgery of the ... Systemic treatm...	18 Years -	Dutch Colorectal Cancer Group

Spots Global Cancer Trial Database for surgery of the primary tumour