UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039077 |
|---|---|
| Receipt number | R000044566 |
| Scientific Title | The HGCSG1901 Study; Multicenter Retrospective Cohort Study Evaluating the Efficacy and Safety of IRIS/Bev in Patients with Metastatic Colorectal Cancer. |
| Date of disclosure of the study information | 2020/01/08 |
| Last modified on | 2025/07/25 23:13:16 |
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Basic information
Public title
The HGCSG1901 Study; Multicenter Retrospective Cohort Study Evaluating the Efficacy and Safety of IRIS/Bev in Patients with Metastatic Colorectal Cancer.
Acronym
HGCSG1901
Scientific Title
The HGCSG1901 Study; Multicenter Retrospective Cohort Study Evaluating the Efficacy and Safety of IRIS/Bev in Patients with Metastatic Colorectal Cancer.
Scientific Title:Acronym
HGCSG1901
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy, safety and efficacy predictors of daily practice use of IRIS/Bev for patients with metastatic or unresectable colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Overall Survival, Response rate, Disease control rate, Safety, Analysis by UGT1A1 polymorphism, Treatment effect predictor, Examination of prognostic factors
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who were treated with IRIS / Bev in primary or secondary treatment.
2)Age <=20 years old at the time of diagnosis.
3)patients who have not rejected the participation of this study from the research subjects or their agent(person who is thought to be able to speak for the will and interest of the research subject).
Key exclusion criteria
1)Participation in the clinical trial is determined as unsuitable.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Komatsu |
Organization
Hokkaido University Hospital
Division name
Cancer Center
Zip code
060-8648
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
ykomatsu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Ito |
Organization
Hokkaido University Hospital
Division name
Cancer Center
Zip code
060-8648
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
Homepage URL
kenito0421@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Gastrointestinal Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Gastrointestinal Cancer Study Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.ac.jp
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
KKR札幌医療センター（北海道）、NTT東日本札幌病院（北海道）、秋田赤十字病院（秋田県）、岩見沢市立総合病院（北海道）、帯広厚生病院（北海道）、北見赤十字病院（北海道）、釧路ろうさい病院（北海道）、恵佑会札幌病院（北海道）、佐野病院（兵庫県）、市立秋田総合病院（秋田県）、市立札幌病院（北海道）、市立函館病院（北海道）、手稲渓仁会病院（北海道）、斗南病院（北海道）、苫小牧市立病院（北海道）、苫小牧日翔病院（北海道）、富山赤十字病院（富山県）、富山大学附属病院（富山県）、函館中央病院（北海道）、弘前大学医学部附属病院（青森県）、北海道医療センター（北海道）、北海道がんセンター（北海道）、北海道大学病院（北海道）、三沢市立三沢病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 08 | Day |
Related information
URL releasing protocol
Conference presentations only
Publication of results
Partially published
Result
URL related to results and publications
Conference presentations only
Number of participants that the trial has enrolled
415
Results
In this retrospective analysis, IRIS/Bev in real world practice showed comparable efficacy and safety to previous report.
IRIS/Bev is one of the standard treatment options for metastatic colorectal cancer as first-line setting.
Results date posted
| 2025 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This multicenter, retrospective, observational cohort study was conducted by the Hokkaido Gastrointestinal Cancer Study Group (HGCSG). We retrospectively reviewed the clinical data of patients with unresectable metastatic colorectal cancer (mCRC) who received S-1 and irinotecan plus bevacizumab (IRIS/Bev) between August 2011 and March 2019 in 24 participating institutions in Japan.
Participant flow
The eligibility criteria were age 20 over years, pathologically or histologically confirmed colorectal adenocarcinoma, received IRIS/Bev as first-line (1L) or second-line (2L) treatment. The study design and protocol were approved by the institutional review board of Hokkaido University Hospital and all other participating institutions. The need for informed consent was waived owing to the retrospective nature of the study. This study was announced on a website.
Adverse events
The adverse events observed during IRIS/Bev treatment are listed in Table 3. The most common adverse events (50% over) were neutrophil count decreased (n = 99, 75.6%), anemia (n = 75, 57.3%), white blood cell decreased (n = 73, 55.7%), diarrhea (n = 72, 55.0%), and fatigue (n = 68, 51.9%) in 1L, and anemia (n = 202, 71.4%), neutrophil count decreased (n = 192, 70.6%), diarrhea (n = 187, 65.8%), white blood cell decreased (n = 171, 60.4%), fatigue (n = 155, 54.6%) and anorexia (n = 149, 52.5%) in 2L. The most frequent severe adverse events (grade 3, 10% over) were neutrophil count decreased (n = 30, 22.9%), white blood cell decreased (n = 14, 10.7%) and hypertension (n = 14, 10.7%) in 1L, and neutrophil count decreased (n = 64, 23.5%), white blood cell decreased (n = 47, 16.6%), diarrhea (n = 47, 16.5%) and anemia (n = 34, 12.0%) in 2L.
No treatment-related adverse events resulted in death in 1L. However, four patients died by treatment related adverse events in 2L. One patient died of severe dyspnea and detailed information was not available. The other patients died by sudden death.
Outcome measures
The following clinical characteristics of the eligible patients were collected: sex, age, Eastern Cooperative Oncology Group performance status (ECOG PS), UGT1A1 status, primary tumor location, prior colorectomy, metastatic organ, RAS/BRAF mutational status and MSI status.
Efficacy was assessed using overall survival (defined as the time from the start of first IRIS/Bev administration to death) and progression free survival (PFS; defined as the time from initiation of IRIS/Bev until tumor progression or death, whichever occurs first). Generally, radiological tumor evaluation was performed by computed tomography every 6-12 weeks after treatment initiation by physicians judgement. Tumor response was evaluated using the Response Evaluation Criteria In Solid Tumors version 1.134. Adverse events were graded using the Common Toxicity Criteria for Adverse Events ver. 5.0. The relative dose intensity (RDI) was defined as the average dose, adjusting for body surface area during the entire treatment course.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Retrospective Cohort Study
Management information
Registered date
| 2020 | Year | 01 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044566
