Clinical trial NCT01712347: An Observational Study of First-Line Bevacizumab (Avastin) With Fluoropyrimidine-Based Chemotherapy in Participants With Metastatic Colorectal Cancer
Official title: An Open-Label, Multicenter, Non-Interventional, Observational Study To Assess The Effect Of First Line Bevacizumab Treatment With Fluoropyrimidine-Based Chemotherapy (CTX) In Patients With Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-23
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with metastatic colorectal cancer receiving first-line bevacizumab in combination with fluoropyrimidine-based chemotherapy

Brief summary: This multicenter observational study will evaluate the efficacy and safety of first-line bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has decided to initiate first-line fluoropyrimidine based chemotherapy in combination with bevacizumab will be observed for approximately 4 years.


Eligibility criteria: Inclusion Criteria:

* Participants with histologically confirmed metastatic colorectal cancer who will receive bevacizumab in combination with first-line fluoropyrimidine-based chemotherapy

Exclusion Criteria:

* Participants not qualified for bevacizumab treatment according to the local label

Primary outcomes:
measure: Overall survival from the time of starting first-line therapy
timeFrame: Start of first line therapy until death (up to approximately 4 years)
Secondary outcomes:
measure: Progression-free survival from the time of starting first-line therapy, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria
timeFrame: Start of first line therapy until death (up to approximately 4 years)
measure: Percentage of participants with best overall response, assessed according to RECIST v.1.1 criteria
timeFrame: Start of first line therapy until death (up to approximately 4 years)
measure: Percentage of participants with liver resection
timeFrame: up to approximately 4 years
measure: Number of participants with adverse events
timeFrame: up to approximately 4 years
Other outcomes:
Locations:
city: Chai Yi
country: Taiwan
facility: Chang Gung Medical Foundation - Chai Yi; Surgery
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital; Colorectal Surgery
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital; Dept of Surgery
city: Tainan
country: Taiwan
facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
city: Taipei
country: Taiwan
facility: Veterans General Hospital; Division of Oncology
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital; Hematology and Oncology
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: