Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673710
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment
Metastatic Colorectal Cancer Other: No intervention

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : March 14, 2016
Actual Primary Completion Date : February 4, 2020
Actual Study Completion Date : February 4, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673710


Locations
Show Show 23 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02673710    
Other Study ID Numbers: ML29985
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Sarcopenia
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical