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Completed

NCT Number: NCT02673710

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

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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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Onze Lieve Vrouwziekenhuis Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

    Time frame: Up to 3 years

  2. 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

    Time frame: Up to 3 years

Secondary outcomes

  1. Participants body weight at initial diagnosis of mCRC

    Time frame: Up to 3 years

  2. Participants body mass index at initial diagnosis of mCRC

    Time frame: Up to 3 years

  3. Participants skeletal muscle mass at initial diagnosis of mCRC

    Time frame: Up to 3 years

  4. Participants visceral fat mass, subcutaneous fat mass, total fat mass at SE

    Time frame: Up to 3 years

  5. Participants Eastern Cooperative Oncology Group Performance status at SE

    Time frame: Up to 3 years

  6. Participant muscle strength at initial diagnosis of mCRC

    Time frame: Up to 3 years

  7. Participants primary and metastases location at Initial Diagnosis

    Time frame: Up to 3 years

  8. Participants mutation status at Initial Diagnosis

    Time frame: Up to 3 years

  9. Participants C-Reactive Protein and Albumin blood values at Initial Diagnosis

    Time frame: Up to 3 years

  10. Participants Date of diagnosis of non-metastatic CRC disease at Initial Diagnosis

    Time frame: Up to 3 years

  11. Participant with 1st line Chemotherapeutic regimen at Initial Diagnosis

    Time frame: Up to 3 years

  12. Functional status using Functional Assessment for Cancer Treatment - specific for Colorectal cancer participants

    Time frame: Up to 3 years

  13. Participant Physical status expressed in muscle strength

    Time frame: Up to 3 years

  14. Participant Physical status expressed in Body Weight

    Time frame: Up to 3 years

  15. Participant Physical status expressed in Body Mass Index

    Time frame: Up to 3 years

  16. Nutritional status using the Patient-Generated Subjective Global Assessment questionnaire

    Time frame: Up to 3 years

  17. Nutritional status using Visual Analogue Scale for appetite

    Time frame: Up to 3 years

  18. Treatment related toxicity using MD Anderson Symptom Inventory scale

    Time frame: Up to 3 years

  19. Number of participants with Number of chemotherapy cycles

    Time frame: Up to 3 years

  20. Number of participants with Number of bevacizumab administrations

    Time frame: Up to 3 years

  21. Number of participants with Treatment changes and treatment (un)changed until Second Progressive Disease

    Time frame: Up to 3 years

  22. Number of participants with Reason for treatment changes

    Time frame: Up to 3 years

  23. Intake dietary supplements

    Time frame: Up to 3 years

  24. Dietary and physical counselling

    Time frame: Up to 3 years

  25. Number of Participants with Adverse Events

    Time frame: Up to 3 years

  26. First Progression Free Survival (PFS1) is defined as the time between initial diagnosis and first progressive disease

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2016
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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