A Study to Assess the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With Chemotherapy Combined With Bevacizumab

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673710
• Other study ID #: ML29985
• Status: Completed
• Start date: March 14, 2016
• Est. completion date: February 4, 2020

Study information

• Verified date: March 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 4, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer
• Sarcopenia

Intervention

Other:
• No intervention
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

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouwziekenhuis Aalst	Aalst
Belgium	AZ Sint Lucas Brugge	Assebroek
Belgium	CHIREC	Auderghem
Belgium	Imeldaziekenhuis	Bonheiden
Belgium	AZ KLINA	Brasschaat
Belgium	AZ Sint Jan	Brugge
Belgium	Institut Jules Bordet X	Brussels
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	Hospital Erasme	Bruxelles
Belgium	Grand Hôpital de Charleroi Notre Dame	Charleroi
Belgium	AZ Maria Middelares	Gent
Belgium	Jessa Zkh (Campus Salvator)	Hasselt
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	CHC MontLégia	Liege
Belgium	CHU Sart-Tilman	Liège
Belgium	AZ St Maarten Campus Leopoldstr	Mechelen
Belgium	Hôpital André Vésale	Montigny-le-Tilleul
Belgium	AZ Damiaan	Oostende
Belgium	AZ Delta (Campus Wilgenstraat)	Roeselare
Belgium	AZ Glorieux- vzw Werken Glorieux	Ronse
Belgium	AZ Nikolaas (Sint Niklaas)	Sint Niklaas
Belgium	AZ Turnhout Sint Elisabeth	Turnhout
Belgium	CHR de Verviers - East Belgium	Verviers

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Participants body weight at initial diagnosis of mCRC		Up to 3 years
Secondary	Participants body mass index at initial diagnosis of mCRC		Up to 3 years
Secondary	Participants skeletal muscle mass at initial diagnosis of mCRC		Up to 3 years
Secondary	Participants visceral fat mass, subcutaneous fat mass, total fat mass at SE		Up to 3 years
Secondary	Participants Eastern Cooperative Oncology Group Performance status at SE		Up to 3 years
Secondary	Participant muscle strength at initial diagnosis of mCRC		Up to 3 years
Secondary	Participants primary and metastases location at Initial Diagnosis		Up to 3 years
Secondary	Participants mutation status at Initial Diagnosis		Up to 3 years
Secondary	Participants C-Reactive Protein and Albumin blood values at Initial Diagnosis		Up to 3 years
Secondary	Participants Date of diagnosis of non-metastatic CRC disease at Initial Diagnosis		Up to 3 years
Secondary	Participant with 1st line Chemotherapeutic regimen at Initial Diagnosis		Up to 3 years
Secondary	Functional status using Functional Assessment for Cancer Treatment - specific for Colorectal cancer participants		Up to 3 years
Secondary	Participant Physical status expressed in muscle strength		Up to 3 years
Secondary	Participant Physical status expressed in Body Weight		Up to 3 years
Secondary	Participant Physical status expressed in Body Mass Index		Up to 3 years
Secondary	Nutritional status using the Patient-Generated Subjective Global Assessment questionnaire		Up to 3 years
Secondary	Nutritional status using Visual Analogue Scale for appetite		Up to 3 years
Secondary	Treatment related toxicity using MD Anderson Symptom Inventory scale		Up to 3 years
Secondary	Number of participants with Number of chemotherapy cycles		Up to 3 years
Secondary	Number of participants with Number of bevacizumab administrations		Up to 3 years
Secondary	Number of participants with Treatment changes and treatment (un)changed until Second Progressive Disease		Up to 3 years
Secondary	Number of participants with Reason for treatment changes		Up to 3 years
Secondary	Intake dietary supplements		Up to 3 years
Secondary	Dietary and physical counselling		Up to 3 years
Secondary	Number of Participants with Adverse Events		Up to 3 years
Secondary	First Progression Free Survival (PFS1) is defined as the time between initial diagnosis and first progressive disease		Up to 3 years