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An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01319877
First received: March 18, 2011
Last updated: July 22, 2016
Last verified: July 2016
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Purpose
This observational study will evaluate the safety and efficacy of Bevacizumab in combination with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese participants with metastatic colorectal cancer. Data will be collected from each participant for up to 3 years.
| Condition |
|---|
| Colorectal Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Multi-center Observational Study of Bevacizumab Plus 5-FU Based Chemotherapy as First Line and Second Line Treatment for Chinese Patients With Metastatic Colorectal Cancer (ML25391) |
Resource links provided by NLM:
MedlinePlus related topics:
Colorectal Cancer
Drug Information available for:
Bevacizumab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Percentage of Participants With Adverse Events [ Time Frame: 36 months ]An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
- Percentage of Participants With Serious Adverse Events [ Time Frame: 36 months ]A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.
- Percentage of Participants With Adverse Events of Special Interest [ Time Frame: 36 months ]
- Percentage of Participants With Bevacizumab-Related Adverse Events [ Time Frame: 36 months ]
- Percentage of Participants With Bevacizumab-related Serious Adverse Events [ Time Frame: 36 months ]
Secondary Outcome Measures:
- Percentage of Participants Achieving an Overall Response [ Time Frame: 36 months ]Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions.
- Progression-free Survival [ Time Frame: 36 months ]Progression-free-survival (PFS) was defined as the time from the date when the participant signed the informed consent form to the time of first documented disease progression or death, whichever occurred first.
- One-year Progression-free Survival Rate [ Time Frame: 1 year ]One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year.
- One-year Survival Rate [ Time Frame: 1 year ]
- Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup [ Time Frame: 36 months ]Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
- One-year Progression-free Survival Rate Per KRAS Subgroup [ Time Frame: 1 year ]One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
- One-year Survival Rate by the KRAS Subgroup [ Time Frame: 1 year ]
- Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup [ Time Frame: Up to 36 Months ]Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' chemotherapy regimen subgroup.
- One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup [ Time Frame: 1 year ]One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' chemotherapy regimen subgroup.
- One-year Survival Rate by the Chemotherapy Regimen Subgroup [ Time Frame: 1 year ]
- Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire [ Time Frame: Up to 36 Months ]Quality of life was assessed at baseline and every three months after treatment by the EORTC QLQ-C30 questionnaire. The possible score range was 0 to 100, with a higher score indicating better functioning.
| Enrollment: | 609 |
| Study Start Date: | March 2011 |
| Study Completion Date: | March 2015 |
| Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
First Line Treatment
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
|
Second Line Treatment
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Participants with metastatic colorectal cancer receiving first-line therapy with Bevacizumab in combination with 5-FU-based chemotherapy
Criteria
Inclusion Criteria:
- Adult Chinese participants, >/= 18 years of age
- Histologically confirmed and previously untreated metastatic colorectal cancer
- Initiated on treatment with Bevacizumab (in combination with 5-FU based chemotherapy) according to locally approved Bevacizumab China package insert
- Documented participant with medical records
Exclusion Criteria:
- Recent history of serious hemorrhage or hemoptysis of >/= 1/2 teaspoon of red blood
- Proteinuria at baseline (>/=2 grams / 24 hours)
- Major surgical procedure within 28 days prior to study treatment start, not fully healed wounds
- Pregnant or lactating women
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319877
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319877
Locations
| China | |
| Beijing, China, 100071 | |
| Beijing, China, 100083 | |
| Changzhou, China, 213003 | |
| Chengdu, China, 610041 | |
| Fuzhou, China, 350014 | |
| Guangzhou, China, 510080 | |
| Guangzhou, China, 510515 | |
| Guangzhou, China, 510655 | |
| Hangzhou, China, 310003 | |
| Hangzhou, China, 310009 | |
| Hangzhou, China, 310022 | |
| Harbin, China, 150040 | |
| Jinan, China, 250117 | |
| Nanjing, China, 210009 | |
| Nanjing, China, 210036 | |
| Nanjing, China | |
| Nanning, China, 530021 | |
| Shanghai, China, 200003 | |
| Shanghai, China, 200032 | |
| Shenyang, China, 110001 | |
| Shenyang, China, 110042 | |
| Wuhan, China, 430079 | |
| Xi'an, China, 710032 | |
| Xiamen, China, 361004 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01319877 History of Changes |
| Other Study ID Numbers: |
ML25391 |
| Study First Received: | March 18, 2011 |
| Results First Received: | April 21, 2016 |
| Last Updated: | July 22, 2016 |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 28, 2017