Registry Platform Colorectal Cancer

Study Overview
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Brief Summary
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The registry aims to collect and analyse information on the antineoplastic treatment of patients with metastatic colorectal cancer, treated in palliative intention in daily routine practice in Germany.

Detailed Description
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AZURITE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic colorectal cancer in Germany. The registry will follow patients for up to three years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Health-related quality of life (HRQoL) will be evaluated for up to three years.

Official Title
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Clinical Research Platform for Molecular Testing, Treatment, Quality of Life and Outcome of Patients With Metastatic Colorectal Cancer Receiving Systemic Therapy (AZURITE)

Conditions
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Colorectal Cancer Metastatic

Intervention / Treatment
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* Other: Physician's choice according to patient's needs.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically proven metastatic colorectal cancer (stage IV) at time of inclusion (patients with metastatic disease and potential curative treatment intention are allowed) Age ≥ 18 years Planned first systemic therapy for metastatic disease Signed and dated informed consent form Patients participating in the PRO module: prior to or at start of first systemic treatment for mCRC Patients not participating in the PRO module: within four weeks after start of fist systemic therapy for mCRC Exclusion Criteria: Patient who do not receive any systemic therapy for mCRC Patients whose metastatic disease was surgically resected prior to inclusion and who start adjuvant chemotherapy

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 |
| --- | --- |
| Colorectal Cancer Metastatic<br> | Other: Physician's choice according to patient's needs.<br>* Routine care as per site standard.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of treatment (treatment reality). | Documentation of anamnestic data and therapy sequences. | 3 years per patient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Response. | Documentation of response rates per line of treatment. | 3 years per patient. | 
| Progression-free survival. | Documentation of progression-free survival per line of treatment. | 3 years per patient. | 
| Overall survival. | Documentation of overall survival per line of treatment. | 3 years per patient. | 
| Health-related quality of life (Patient-reported outcome, PRO). | EORTC QLQ-C30 core questionnaire [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high scale score represents a higher response level: (a) global health status: a high score represents high quality of life, (b) functional scales: a high score represents high/healthy level of functioning, (c) symptom scales/items: a high score represents high level of symptomatology or problems]. | 3 years per patient. | 
| Carcinoma Health-related quality of life (Patient-reported outcome, PRO). | EORTC QLQ-CR29 [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high score for scales and single items represents a high level of symptomatology or problems]. | 3 years per patient. |