UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043200 |
|---|---|
| Receipt number | R000049304 |
| Scientific Title | Multicenter retrospective study of ramucirumab-containing chemotherapy for patients with gastrointestinal neuroendocrine carcinoma who are refractory or intolerant to platinum-based chemotherapy(WJOG13420G) |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2024/02/05 09:09:46 |
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Basic information
Public title
Multicenter retrospective study of ramucirumab-containing chemotherapy for patients with gastrointestinal neuroendocrine carcinoma who are refractory or intolerant to platinum-based chemotherapy(WJOG13420G)
Acronym
Multicenter retrospective study of ramucirumab-containing chemotherapy for patients with gastrointestinal neuroendocrine carcinoma(WJOG13420G)
Scientific Title
Multicenter retrospective study of ramucirumab-containing chemotherapy for patients with gastrointestinal neuroendocrine carcinoma who are refractory or intolerant to platinum-based chemotherapy(WJOG13420G)
Scientific Title:Acronym
Multicenter retrospective study of ramucirumab-containing chemotherapy for patients with gastrointestinal neuroendocrine carcinoma who are refractory or intolerant to platinum-based chemotherapy(WJOG13420G)
Region
| Japan |
Condition
Condition
Gastric or colorectal neuroendocrine carcinoma (NEC)
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To examine the efficacy of the ramucirumab containing chemotherapy on gastric or colorectal neuroendocrine carcinoma (NEC) refractory or intolerant to systemic platinum-based chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression-free survival
Response rate
Disease control rate
Duration of response
Adverse event
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) Meets one of the following histological diagnosis requirements taking immunohistochemical staining into account.
1. Pathological examination of a resected specimen led to a diagnosis of NEC
2. Diagnosed as Mixed adenoneuroendocrine carcinoma (tumors in which there is a mixture of >=30% of adenocarcinoma and NEC) based on resected specimen
2) The primary organ is the stomach or colorectum.
3) Distant metastasis or recurrent lesions that cannot be radically resected.
4) Refractory or intolerant to systemic platinum-based chemotherapy in the primary treatment. The secondary treatment has been implemented within 6 months from the final administration of the primary treatment.
5) Ramucirumab containing chemotherapy (secondary treatment in case of no ramucirumab) was started during the following periods:
1. Gastric NEC: Between March 2015 and June 2020
2. Colorectal NEC: Between May 2016 and June 2020
6) ECOG PS is determined as follows:
1. Group A (cases that include ramucirumab containing chemotherapy for secondary treatment or beyond)
ECOG PS at the start of ramucirumab combination therapy is 0-2.
2. Group B (cases that do not include ramucirumab containing chemotherapy for secondary treatment or beyond)
ECOG PS at the start of the secondary treatment is 0-2.
Key exclusion criteria
1) History of ramucirumab administration before the start of the secondary treatment
2) If the attending physician or study supervising physician determined the case to be unsuitable
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Masuishi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa Ward, Nagoya City, Aichi Prefecture
TEL
052-762-6111
tmasuishi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan 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
Certified Review Board of Aichi Cancer Center
Address
1-1,Kanokoden,Chikusa-ku, Nagoya, Aichi
Tel
052-762-6111
irb@aichi-cc.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
| 2021 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Study Design]
Multicenter retrospective study
[Recruitment]
Recruiting through WJOG
[Objectives]
To examine the efficacy of the ramucirumab containing chemotherapy on gastric or colorectal neuroendocrine carcinoma(NEC) refractory or intolerant to systemic platinum-based chemotherapy.
[Planed period]
Study period:3 year from ethical approval
Registration period:18 months from the start of the registration
Analytical period:18 months from the end of the registration
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049304
