UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028897 |
|---|---|
| Receipt number | R000032819 |
| Scientific Title | ZALTRAP Special Drug Use Surveillance (Unresectable advanced and/or recurrent colorectal cancer) |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2023/05/12 16:03:55 |
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Basic information
Public title
ZALTRAP Special Drug Use Surveillance (Unresectable advanced and/or recurrent colorectal cancer)
Acronym
ZALTRAP Special Drug Use Surveillance (Unresectable advanced and/or recurrent colorectal cancer)
Scientific Title
ZALTRAP Special Drug Use Surveillance (Unresectable advanced and/or recurrent colorectal cancer)
Scientific Title:Acronym
ZALTRAP Special Drug Use Surveillance (Unresectable advanced and/or recurrent colorectal cancer)
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To collect safety and effectiveness information of ZALTRAP used in the real post-marketing setting in patients with unresectable advanced and/or recurrent colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety: Incidence rate of adverse drug reaction
Effectiveness: Tumor assessment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients with unresectable advanced and/or recurrent colorectal cancer
-Patients newly treated by ZALTRAP
Key exclusion criteria
Patients concurrently participating in any interventional clinical studies
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | SUZUKI |
Organization
Sanofi K.K.
Division name
Post-marketing regulatory study, Medical Affairs
Zip code
163-1488
Address
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan
TEL
03-6301-3867
Sanofi_Medical@sanofi.com
Public contact
Name of contact person
| 1st name | Public contact for Drug use surveillance |
| Middle name | |
| Last name | - |
Organization
Sanofi K.K.
Division name
Post-marketing regulatory study, Medical Affairs
Zip code
163-1488
Address
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan
TEL
03-6301-3867
Homepage URL
Sanofi_Medical@sanofi.com
Sponsor or person
Institute
Sanofi K.K.
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
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
Not applicable because of Drug use surveillance
Address
Not applicable because of Drug use surveillance
Tel
-
-
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
| 2017 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36307632/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36307632/
Number of participants that the trial has enrolled
261
Results
The incidence of adverse reactions in this study was lower than that occurred at the time of approval of the drug.The benefit-risk assessment of Zaltrap in this study was favorable and it was judged that there was no additional safety concerns identified.
Results date posted
| 2023 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Overall, 235 patients (females, n=110, males, n=125) were included in the safety analysis. The mean age was 64.1 years; 147 patients (62.6%) had a colon cancer and 85 patients (36.2%) had a rectal cancer. Overall, 72 patients (30.6%) had a right-sided colon tumor, 162 patients (68.9%) had a left-sided colon tumor or a rectum cancer, 100 patients (42.6%) were RAS wild type and 128 patients (54.5%) were RAS mutant. All patients were metastatic at the time of aflibercept initiation (mainly liver metastases, n=137, 58.3%). FOLFIRI + aflibercept was administered in 1st line in 3 patients (1.3%), in 2nd line in 113 patients (48.1%), in 3rd line in 52 patients (22.1%), in 4th line in 28 patients (11.9%), in 5th line in 16 patients (6.8%) and 6th line or later in 22 patients (9.4%). Overall, 125 patients (53.2%) had received prior bevacizumab, 23 (9.8%) had received prior ramucirumab, 87 (37.0%) had nether received prior bevacizumab nor ramucirumab and 128 patients (54.5%) were previously treated with an oxaliplatin-based regimen. Aflibercept was combined with FOLFIRI in 230 patients (97.9%), a chemotherapy other than FOLFIRI in 3 patients (irinotecan alone in 3 patients and tegafur/gimeracil/oteracil in 1 patient).
Participant flow
261 patients were registered at 64 sites, and the CRFs of 245 patients were collected. Of these 245 patients, 235 were exposed to study drug and included in the safety analysis dataset and 10 patients were excluded from the safety analysis. Of these 235 patients exposed to FOLFIRI + aflibercept, 198 patients were included in the efficacy analysis.
Adverse events
Adverse reactions assessed by both physicians and the company as "related" occurred in 167 (71.06%) of 235 patients included in the safety analysis. The most common reactions were proteinuria in 58 patients (24.68%), neutrophil count decreased in 44 patients (18.72%), hypertension in 39 patients (16.60%), stomatitis and white blood cell count decreased in 16 patients (6.81%), decreased appetite and diarrhoea in 14 patients (5.96%). The most common adverse events were neutropenia in 81 patients (34.47%), proteinuria in 58 patients (24.68%), hypertension and diarrhea in 40 patients (17.02%) each.
Outcome measures
In EFC11885 study which was the Japanese study at the time of approval, the response rate (CR+PR) [95% confidence interval] (%) was 8.3 [1.3-15.3] (5/60) based on RECIST1.1. In this survey, the response rate was 5.5% [2.5-10.1] (9/165) according to RECIST1.1. And the disease control rate was 78/165 (47.3%). The overall response rate was maximum in second-line setting (8/86, 9.3%) and decreased in subsequent lines. The response rate was similar with that at the time of approval of the drug.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 29 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 19 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 23 | Day |
Other
Other related information
Patient's backgrounds, Previous treatments against colorectal cancer, Zaltrap administration status, Concomitant drug against colorectal cancer, etc.
Management information
Registered date
| 2017 | Year | 08 | Month | 30 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032819
