Clinical trial NCT02673710: A Study to Assess the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With Chemotherapy Combined With Bevacizumab
Official title: A Multicenter Non-Interventional Study Exploring the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With a Chemotherapy Combined With Bevacizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients treated in first line with bevacizumab for whom it is decided, and who are clinically considered eligible, to continue the treatment with bevacizumab beyond PD1.
* Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.
* Availability of specific retrospective data at diagnosis and during 1st line treatment

Exclusion Criteria:

* Patients who are participating or participated in first line in any other interventional clinical trial involving non-standard of care procedures impacting the body composition
* Dementia or another mental condition making it impossible to fill out questionnaires

Primary outcomes:
measure: 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
timeFrame: Up to 3 years
measure: 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
timeFrame: Up to 3 years
Secondary outcomes:
measure: Participants body weight at initial diagnosis of mCRC
timeFrame: Up to 3 years
measure: Participants body mass index at initial diagnosis of mCRC
timeFrame: Up to 3 years
measure: Participants skeletal muscle mass at initial diagnosis of mCRC
timeFrame: Up to 3 years
measure: Participants visceral fat mass, subcutaneous fat mass, total fat mass at SE
timeFrame: Up to 3 years
measure: Participants Eastern Cooperative Oncology Group Performance status at SE
timeFrame: Up to 3 years
measure: Participant muscle strength at initial diagnosis of mCRC
timeFrame: Up to 3 years
measure: Participants primary and metastases location at Initial Diagnosis
timeFrame: Up to 3 years
measure: Participants mutation status at Initial Diagnosis
timeFrame: Up to 3 years
measure: Participants C-Reactive Protein and Albumin blood values at Initial Diagnosis
timeFrame: Up to 3 years
measure: Participants Date of diagnosis of non-metastatic CRC disease at Initial Diagnosis
timeFrame: Up to 3 years
measure: Participant with 1st line Chemotherapeutic regimen at Initial Diagnosis
timeFrame: Up to 3 years
measure: Functional status using Functional Assessment for Cancer Treatment - specific for Colorectal cancer participants
timeFrame: Up to 3 years
measure: Participant Physical status expressed in muscle strength
timeFrame: Up to 3 years
measure: Participant Physical status expressed in Body Weight
timeFrame: Up to 3 years
measure: Participant Physical status expressed in Body Mass Index
timeFrame: Up to 3 years
measure: Nutritional status using the Patient-Generated Subjective Global Assessment questionnaire
timeFrame: Up to 3 years
measure: Nutritional status using Visual Analogue Scale for appetite
timeFrame: Up to 3 years
measure: Treatment related toxicity using MD Anderson Symptom Inventory scale
timeFrame: Up to 3 years
measure: Number of participants with Number of chemotherapy cycles
timeFrame: Up to 3 years
measure: Number of participants with Number of bevacizumab administrations
timeFrame: Up to 3 years
measure: Number of participants with Treatment changes and treatment (un)changed until Second Progressive Disease
timeFrame: Up to 3 years
measure: Number of participants with Reason for treatment changes
timeFrame: Up to 3 years
measure: Intake dietary supplements
timeFrame: Up to 3 years
measure: Dietary and physical counselling
timeFrame: Up to 3 years
measure: Number of Participants with Adverse Events
timeFrame: Up to 3 years
measure: First Progression Free Survival (PFS1) is defined as the time between initial diagnosis and first progressive disease
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouwziekenhuis Aalst
city: Assebroek
country: Belgium
facility: AZ Sint Lucas Brugge
city: Auderghem
country: Belgium
facility: CHIREC
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brasschaat
country: Belgium
facility: AZ KLINA
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Brussels
country: Belgium
facility: Institut Jules Bordet X
city: Bruxelles
country: Belgium
facility: Hospital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi Notre Dame
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Salvator)
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liege
country: Belgium
facility: CHC MontLégia
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Mechelen
country: Belgium
facility: AZ St Maarten Campus Leopoldstr
city: Montigny-le-Tilleul
country: Belgium
facility: Hôpital André Vésale
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Roeselare
country: Belgium
facility: AZ Delta (Campus Wilgenstraat)
city: Ronse
country: Belgium
facility: AZ Glorieux- vzw Werken Glorieux
city: Sint Niklaas
country: Belgium
facility: AZ Nikolaas (Sint Niklaas)
city: Turnhout
country: Belgium
facility: AZ Turnhout Sint Elisabeth
city: Verviers
country: Belgium
facility: CHR de Verviers - East Belgium
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: