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The purpose of this study is to explore the relationship between sarcopenia, as defined by computed tomography, treatment related outcomes and other body composition related parameters in a patient population receiving bevacizumab beyond progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with metastatic colorectal cancer | Participants diagnosed with mCRC treated in first line with a combination of bevacizumab and chemotherapy for whom it is decided to continue the administration of bevacizumab beyond progression while changing CTR will be included in this study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Besides participant reported outcomes and a muscle strength test no interventions are administered, all treatment decisions are at the discretion of the physician and will be in line with local clinical practice and labeling |
| Measure | Description | Time Frame |
|---|---|---|
| Second Progression Free Survival (PFS2) defined as the time interval between study entry and the date of progression or death for any cause, whichever occurs first | Up to 3 years | |
| Sarcopenia quantified via CT-scan defined as a skeletal muscle index at the 3rd lumbar vertebra below 41 for women and below 43 or 53 for men with a Body Mass Index below or above 25 respectively | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Participants body weight at initial diagnosis of mCRC | Up to 3 years | |
| Participants body mass index at initial diagnosis of mCRC | Up to 3 years | |
| Participants skeletal muscle mass at initial diagnosis of mCRC |
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Inclusion Criteria:
Exclusion Criteria:
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Participants diagnosed with mCRC treated in first line with a combination of bevacizumab and chemotherapy for whom it is decided to continue the administration of bevacizumab beyond progression while changing chemotherapy regimen (CTR) will be included in this study
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouwziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| AZ Sint Lucas Brugge |
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| Up to 3 years |
| Participants visceral fat mass, subcutaneous fat mass, total fat mass at SE | Up to 3 years |
| Participants Eastern Cooperative Oncology Group Performance status at SE | Up to 3 years |
| Participant muscle strength at initial diagnosis of mCRC | Up to 3 years |
| Participants primary and metastases location at Initial Diagnosis | Up to 3 years |
| Participants mutation status at Initial Diagnosis | Up to 3 years |
| Participants C-Reactive Protein and Albumin blood values at Initial Diagnosis | Up to 3 years |
| Participants Date of diagnosis of non-metastatic CRC disease at Initial Diagnosis | Up to 3 years |
| Participant with 1st line Chemotherapeutic regimen at Initial Diagnosis | Up to 3 years |
| Functional status using Functional Assessment for Cancer Treatment - specific for Colorectal cancer participants | Up to 3 years |
| Participant Physical status expressed in muscle strength | Up to 3 years |
| Participant Physical status expressed in Body Weight | Up to 3 years |
| Participant Physical status expressed in Body Mass Index | Up to 3 years |
| Nutritional status using the Patient-Generated Subjective Global Assessment questionnaire | Up to 3 years |
| Nutritional status using Visual Analogue Scale for appetite | Up to 3 years |
| Treatment related toxicity using MD Anderson Symptom Inventory scale | Up to 3 years |
| Number of participants with Number of chemotherapy cycles | Up to 3 years |
| Number of participants with Number of bevacizumab administrations | Up to 3 years |
| Number of participants with Treatment changes and treatment (un)changed until Second Progressive Disease | Up to 3 years |
| Number of participants with Reason for treatment changes | Up to 3 years |
| Intake dietary supplements | Up to 3 years |
| Dietary and physical counselling | Up to 3 years |
| Number of Participants with Adverse Events | Up to 3 years |
| First Progression Free Survival (PFS1) is defined as the time between initial diagnosis and first progressive disease | Up to 3 years |
| Assebroek |
| 8310 |
| Belgium |
| CHIREC | Auderghem | 1160 | Belgium |
| Imeldaziekenhuis | Bonheiden | 2820 | Belgium |
| AZ KLINA | Brasschaat | 2930 | Belgium |
| AZ Sint Jan | Bruges | 8000 | Belgium |
| Institut Jules Bordet X | Brussels | 1000 | Belgium |
| Hospital Erasme | Brussels | 1070 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| Grand Hôpital de Charleroi Notre Dame | Charleroi | 6000 | Belgium |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| Jessa Zkh (Campus Salvator) | Hasselt | 3500 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHC MontLégia | Liège | 4000 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| AZ St Maarten Campus Leopoldstr | Mechelen | 2800 | Belgium |
| Hôpital André Vésale | Montigny-le-Tilleul | 6110 | Belgium |
| AZ Damiaan | Ostend | 8400 | Belgium |
| AZ Delta (Campus Wilgenstraat) | Roeselare | 8800 | Belgium |
| AZ Glorieux- vzw Werken Glorieux | Ronse | 9600 | Belgium |
| AZ Nikolaas (Sint Niklaas) | Sint-Niklaas | 9100 | Belgium |
| AZ Turnhout Sint Elisabeth | Turnhout | 2300 | Belgium |
| CHR de Verviers - East Belgium | Verviers | 4800 | Belgium |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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