Treatment Strategies for Primarily Generalized Colorectal Cancer

Study Overview
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Brief Summary
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For patients with primarily generalized colorectal cancer two treatment strategies are compared to establish which strategy gives best overall survival. The traditional strategy is to first resect the primary colorectal tumour and then treat the metastases with chemotherapy followed if possible by surgery. The alternative strategy is to first treat the metastases with chemotherapy followed if possible by surgery and only resect the primary colorectal tumour if there is hope for cure or if symptoms develop that necessitates treatment.

Detailed Description
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Patients are randomized between the two treatment strategies mentioned above. After initial treatment the patients are categorized as palliative or treated with curative intent. Patients are followed with quality of life evaluations every 6 months. Outpatient visits, hospital care, examinations and treatment are recorded as well as complications and side effects. Survival is recorded and for those patients treated with curative intent the tumour situation 3 years after randomization is evaluated.

Official Title
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Treatment Strategies for Primarily Generalized Colorectal Cancer Prospective Randomized Comparison Between Two Treatment Strategies

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Chemotherapy and surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primarily generalized colorectal cancer diagnosed by pathology or typical appearance on x-ray or at endoscopy and where there is uncertainty regarding best treatment strategy Exclusion Criteria: Patients not willing to participate or unable to sign informed consent. Patients with other malignancy with metastatic potential Patients where synchronous resection of primary tumour and metastases is planned Patients not fit for chemotherapy or surgery Patients with locally unresectable primary tumours Patients with symptoms from primary colorectal tumour necessitating resection
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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional strategy<br>First resection of the primary colorectal tumour, then treatment of metastases with chemotherapy and if possible surgery. | Procedure: Chemotherapy and surgery<br>* Treatment not specified but in accordance with national guidelines<br>|
| Active Comparator: Alternative strategy<br>First treatment of metastases with chemotherapy and if possible surgery, later resection of primary colorectal tumour if hope for cure or if symptoms develope that necessitates treatment | Procedure: Chemotherapy and surgery<br>* Treatment not specified but in accordance with national guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years after completion of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year survival for patients treated with curative intent |  | 3 years after randomization | 
| Palliative patients not receiving chemotherapy treated with the traditional strategy |  | Completion of study | 
| Quality of life |  | Every 6 months up to 3 years | 
| Health care consumption |  | Completion of study | 
| Complications and side effects |  | Completion of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Metastases, Treatment strategies, Colorectal cancer with synchronous metastases