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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name