UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039590 |
|---|---|
| Receipt number | R000045148 |
| Scientific Title | Treatment patterns and outcomes in patients with metastatic colorectal cancer based on analysis of a health insurance claim database |
| Date of disclosure of the study information | 2020/02/26 |
| Last modified on | 2023/10/28 19:11:55 |
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Basic information
Public title
Treatment patterns and outcomes in patients with metastatic colorectal cancer based on analysis of a health insurance claim database
Acronym
Treatment patterns and outcomes in patients with metastatic colorectal cancer based on analysis of a health insurance claim database
Scientific Title
Treatment patterns and outcomes in patients with metastatic colorectal cancer based on analysis of a health insurance claim database
Scientific Title:Acronym
Treatment patterns and outcomes in patients with metastatic colorectal cancer based on analysis of a health insurance claim database
Region
| Japan |
Condition
Condition
metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1.To evaluate the efficacy and safety in each first-line chemotherapy given to vulnerable patients with metastatic colorectal cancer based on a health insurance claim database
2.To evaluate the efficacy and safety in each angiogenesis inhibitor in second-line treatment for patients with metastatic colorectal cancer based on a health insurance claim database
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
1.TTF:Time to Treatment Failure
2.TFST:Time to First Subsequent Therapy
3.OS:Overall Survival
4.Tumor Maker
Safety
1.Hematological Toxicities
2.non-Hematological Toxicities
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Metastatic colorectal cancer
2.First-line or second-line chemotherapy was initiated between April 2008 and September 2019
Key exclusion criteria
Nothing in particular
Target sample size
471230
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamazaki |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
k.yamazaki@scchr.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamazaki |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
Homepage URL
k.yamazaki@scchr.jp
Sponsor or person
Institute
the 22nd Century Cutting-Edge Medical Information Technology Organization
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401,Mita, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
https://www.futuremedicine.com/doi/10.2217/fon-2022-1284
Number of participants that the trial has enrolled
3136
Results
As this study used a retrospective cohort design, we cannot make definite conclusions. However, in terms of TTF, BEV seemed to be a favorable option compared with ramucirumab and aflubercept when combined with FOLFIRI, and IRIS might be a preferred option compared to FOLFIRI when combined with bevacizumab for patients who failed to respond to fluoropyrimidine, oxaliplatin, and bevacizumab.
Results date posted
| 2023 | Year | 10 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1,850 patients received FOLFIRI plus bevacizumab, 469 FOLFIRI plus ramucirumab, 105 FOLFIRI plus aflibercept, 581 IRIS plus bevacizumab and 131 CAPIRI plus bevacizumab. No patients received ramucirumab or aflibercept before 2016 due to the timing of drug reimbursement; for patients who received FOLFIRI-based treatment, the rates of FOLFIRI+ramucirumab and FOLFIRI+aflibercept in large hospitals (>=500 beds) or designated cancer hospitals were higher than FOLFIRI+bevacizumab. For patients treated with bevacizumab, the rates of IRIS+bevacizumab and CAPIRI+bevacizumab were higher than FOLFIRI+bevacizumab in large hospitals (>=500 beds) or designated cancer hospitals. IRIS+bevacizumab and CAPIRI+bevacizumab were also more frequently performed at Stage I-III at diagnosis, primary treatment TTF >=6 months and after 2016 compared to FOLFIRI+bevacizumab. In addition, more than 90% of patients who received IRIS+bevacizumab and CAPIRI+bevacizumab also received CAPOX+bevacizumab and SOX+bevacizumab as first-line treatment. In contrast, there were no differencies in age, gender, primary tumor location, or ADL.
Participant flow
Using 471,230 patients registered in the MDV database between 1 January 2008 and 30 September 2019 with suspected colorectal malignancies, the analysis included patients who received the combination therapy of fluoropyrimidine, oxaliplatin, and bevacizumab as primary treatment for metastatic colorectal cancer, followed by the combination therapy of fluoropyrimidine, irinotecan, and angiogenesis inhibitor as second-line treatment.
Adverse events
The frequency of neutropenia or febrile neutropenia requiring G-CSF administration was 16.4% for FOLFIRI+bevacizumab, 16.8% for FOLFIRI+ramucirumab, 15.2% for FOLFIRI+aflibercept, 10.3% for IRIS+bevacizumab, and 8.4% for CAPIRI+bevacizumab, which were significantly lower for IRIS+bevacizumab (P <.001) and CAPIRI+bevacizumab (P =.022) compared with FOLFIRI+bevacizumab. The frequency of adverse events requiring hospitalisation was 10.9% for FOLFIRI+bevacizumab, 11.9% for FOLFIRI+ramucirumab, 6.7% for FOLFIRI+aflibercept, 11.5% for IRIS+bevacizumab, and 12.2% for CAPIRI+bevacizumab, with no significant differences.
Outcome measures
Median follow-up was 20.7 months for FOLFIRI+bevacizumab, 11.1 months for FOLFIRI+ramucirumab, 8.1 months for FOLFIRI+aflibercept, 14.8 months for IRIS+bevacizumab and 12.5 months for CAPIRI+bevacizumab.
Primary endpoint:
In patients treated with FOLFIRI-based therapy, the median TTF was 4.2 months for FOLFIRI+bevacizumab (95% CI, 3.7-4.4), 2.8 months for FOLFIRI+ramucirumab (95% CI, 2.5-3.3) and 3.0 months for FOLFIRI+aflibercept (95% CI, 2.1-3.8), significantly better with FOLFIRI+bevacizumab (vs. FOLFIRI+ramucirumab HR, 1.40; 95% CI, 1.26-1.56; P <.001, vs. FOLFIRI+aflibercept HR, 1.34; 95% CI, 1.09-1.66; P =.002).
In patients treated with bevacizumab, the median TTF was 4.2 months for FOLFIRI+bevacizumab (95% CI, 3.7-4.4), 5.0 months for IRIS+bevacizumab (95% CI, 4.4-5.6) and 4.9 months for CAPIRI+bevacizumab (95% CI, 3.9-6.2), significantly better with IRIS+bevacizumab compared with FOLFIRI+bevacizumab (HR, 0.80; 95% CI, 0.70-0.92; P =.002), but not with CAPIRI+bevacizumab (HR, 0.90; 95% CI, 0.73-1.11; P =.268) .
Secondary endpoints:
In patients treated with FOLFIRI-based therapy, the median TFST was 6.6 months for FOLFIRI+bevacizumab (95% CI, 6.3-6.8), 5.5 months for FOLFIRI+ramucirumab (95% CI, 4.9-5.8), 6.4 months for FOLFIRI+aflibercept (95% CI , 5.1-9.2), which was significantly shorter for FOLFIRI+ramucirumab compared with FOLFIRI+bevacizumab (HR, 1.32; 95% CI, 1.17-1.49; P <.001), but not significantly different for FOLFIRI+aflibercept (HR, 1.03; 95 CI, 0.79-1.35; P =.417). The median OS was 18.2 months for FOLFIRI+bevacizumab (95% CI, 17.1-19.9), 16.6 months for FOLFIRI+ramucirumab (95% CI, 14.3-21.4) and 16.4 months for FOLFIRI+aflibercept (95 CI, 14.5-NA), there was no significant difference compared with FOLFIRI+bevacizumab (vs. FOLFIRI+ramucirumab HR, 1.15; 95% CI, 0.97-1.37; P =.063, vs. FOLFIRI+aflibercept HR, 0.88; 95% CI, 0.58- 1.34; P =.799).
In patients treated with bevacizumab, the median TFST was 6.6 months for FOLFIRI+bevacizumab (95% CI, 6.3-6.8), 7.9 months for IRIS+bevacizumab (95% CI, 7.3-8.7) and 7.6 months for CAPIRI+bevacizumab (95% CI, 6.9-8.6), there was no significant difference compared with FOLFIRI+bevacizumab (vs. IRIS+bevacizumab HR, 0.84; 95% CI, 0.73-0.98; P =.043, vs. CAPIRI+bevacizumab HR, 0.92; 95% CI, 0.73-1.16; P =.353). The median OS was 18.2 months (95% CI, 17.1-19.9) for FOLFIRI+bevacizumab, 22.0 months (95% CI, 19.6-24.5) for IRIS+bevacizumab, 24.2 months (95% CI, 21.2-34.4) for CAPIRI+bevacizumab, there was no significant difference compared with FOLFIRI+bevacizumab (vs. IRIS+bevacizumab HR, 0.83; 95% CI, 0.68-1.01; P =.144, vs. CAPIRI+bevacizumab HR, 0.70; 95% CI, 0.50-0.99; P =.247).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 11 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 27 | Day |
Other
Other related information
Uses medical information of DPC Hospital from April 2008 to September 2019 held by Medical Data Vision Co., Ltd. (MDV).
Key inclusion criteria
1. Metastatic colorectal cancer
2. 20 to 90 years
Management information
Registered date
| 2020 | Year | 02 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045148
