UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033376 |
|---|---|
| Receipt number | R000038036 |
| Scientific Title | Observational Multicenter Study of Relationship between Peripheral Neuropathy and Effectiveness in 2nd Line Therapy for Unresectable Advanced Gastric Cancer |
| Date of disclosure of the study information | 2018/09/15 |
| Last modified on | 2024/07/17 16:06:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational Multicenter Study of Relationship between Peripheral Neuropathy and Effectiveness in 2nd Line Therapy for Unresectable Advanced Gastric Cancer
Acronym
IVY Study
Scientific Title
Observational Multicenter Study of Relationship between Peripheral Neuropathy and Effectiveness in 2nd Line Therapy for Unresectable Advanced Gastric Cancer
Scientific Title:Acronym
IVY Study
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination of relationship between peripheral neuropathy and effectiveness in 2nd line therapy for unresectable advanced gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relationship between frequency of peripheral neuropathy and effectiveness of chemotherapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)This is a case of unresectable or recurrent gastric cancer histologically confirmed to be the primary adenocarcinoma of the stomach.
2)Patient's age is over than 20 years old
3)Cases with Performance Status (PS) of 0-2 in ECOG
4)Patients who have been fully informed of this study and have given written informed consent
5)Patients resisted first line chemotherapy consisted of fluorinated pyrimidine anticancer drugs (e.g., 5-FU, S-1, capecitabine, UFT) and platinum anticancer drugs (cisplatin or oxaliplatin) for unresectable or recurrent gastric cancer.
Key exclusion criteria
1)Patient's prognosis is within three months
2)With severe complications (angina pectoris, myocardial infarction and arrhythmia) and uncontrollable DM, blood hypertension and bleeding tendency
3)History of serious allergic reaction and with serious drug allergy
4)With clinically relevant mental disorder to be unable to answer questionnaires
5)Patients for whom the attending physician considered enrollment in the study inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Tanioka |
Organization
Kawasaki Medical School
Division name
Department of Clinical Oncology
Zip code
7010192
Address
577 Matsushima, Kurashiki City Okayama 701-0192, Japan
TEL
0864621111
tanioka@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Tanioka |
Organization
Kawasaki Medical School
Division name
Department of Clinical Oncology
Zip code
7010192
Address
577 Matsushima, Kurashiki City Okayama 701-0192, Japan
TEL
0864621111
Homepage URL
tanioka@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima, Kurashiki City Okayama 701-0192, Japan
Tel
0864621111
kmsrec@med.kawasaki-m.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.annalsofoncology.org/article/S0923-7534(19)30636-2/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.annalsofoncology.org/article/S0923-7534(23)02334-7/fulltext
Number of participants that the trial has enrolled
162
Results
The group with PN at the start of the second-line treatment had a higher incidence of severe PN during the treatment (16.7% vs 4.6%, p=0.02). The overall response rate was not significantly different between the two groups (23% in the group with PN vs 19% in the group without PN, p=0.69). However, the median overall survival was significantly better in the group with PN (10.3 months with PN vs 8.1 months without PN, p=0.04).
Results date posted
| 2024 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In a study of 162 patients with gastric cancer, 156 of them received second-line chemotherapy treatment and were divided into two groups based on their PN grade at the start of the treatment. The characteristics of the patients are as follows: the median age was 69 years, 72% were male, 52% had ECOG PS 0/1/2, 81% used Oxaliplatin in their first-line chemotherapy regimen, 58% had PSN at the start of the second-line chemotherapy, and 84% used ramucirumab in their second-line chemotherapy regimen.
Participant flow
In IVY study (UMIN000033376), we examined the influence of first-line platinuminduced PN on the incidence of PN during PTX containing nab-PTX as second-line CTx and on the efficacy for AGC pts.
Adverse events
Peripheral sensory neuropathy appeared in 59% in the group without PN and 92% in the group with PN.Peripheral motor neuropathy appeared in 14% in the group without PN and 39% in the group with PN.
Outcome measures
The primary endpoint was the incidence of grade 3 to 4 peripheral sensory neuropathy (PSN) (CTCAE version 4.0) during second-line PTX in pts with and without PSN at the start of second-line PTX. The secondary endpoints were the relationship between the degree of PSN and the efficacy of second-line PTX.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038036
