UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023065 |
|---|---|
| Receipt number | R000026585 |
| Scientific Title | An intergroup phase III trial of Ramucirumab plus Irinotecan in third or more line Beyond progression after Ramucirumab for Advanced Gastric cancer. |
| Date of disclosure of the study information | 2016/07/13 |
| Last modified on | 2024/07/20 06:52:51 |
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Basic information
Public title
An intergroup phase III trial of Ramucirumab plus Irinotecan in third or more line Beyond progression after Ramucirumab for Advanced Gastric cancer.
Acronym
RINDBeRG trial
Scientific Title
An intergroup phase III trial of Ramucirumab plus Irinotecan in third or more line Beyond progression after Ramucirumab for Advanced Gastric cancer.
Scientific Title:Acronym
RINDBeRG trial
Region
| Japan |
Condition
Condition
gastric or gastroesophageal cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will evaluate the efficacy and safety of adding RAM to IRI, versus IRI monotherapy, in patients with advanced or recurrent gastric or gastroesophageal cancer who experienced disease progression while receiving a RAM-containing regimen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
overall survival (OS)
Key secondary outcomes
progression-free survival (PFS); time to treatment failure (TTF); response rate (RR); disease control rate (DCR); and adverse events (AEs)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Irinotecan alone
IRI 150 mg/m2, day 1 q2w
Interventions/Control_2
Ramucirumab plus irinotecan
RAM 8 mg/kg day1, q2w
IRI 150 mg/m2, day1, q2w
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)Histopathologically confirmed adenocarcinoma of gastric or gastroesophageal junction (GEJ) with inoperable, locally advanced or metastatic disease, not amenable to curative therapy.
2)Documented objective radiographic or clinical disease progression after a ramucirumab-containing chemotherapy.
3)No previous history of IRI administration.
4)Neither tolerates nor responds to treatment with fluoropyrimidines, platinum, or taxanes.
5)Has lesions that can be evaluated on CT or MRI images.
6)Age at enrollment 20 years old <=.
7)ECOG performance status (PS) of 0 or 1 at study entry.
8)Oral intake is possible.
9)Adequate organ function, defined as no severe impairment of bone marrow, heart, lungs, liver or kidneys, and laboratory values at the start of treatment that meet the following criteria.
10)Life expectancy of at least 3 months.
11)Written informed consent obtained prior to any study-specific procedures.
Key exclusion criteria
1)History of another malignancy
2)Previous systemic chemotherapy with an angiogenesis inhibitor, except ramucirumab.
3)History of serious adverse events after treatment with RAM.
4)Uncontrolled arterial hypertension.
5)Uncontrollable diarrhea that interferes with everyday activities even if receiving adequate treatment.
6)Undergoing anticoagulant therapy for the treatment of thromboembolism.
7)Local or systemic active infection that requires treatment.
8)Serious illness or medical condition(s)
9)History of severe allergy or hypersensitivity to any drugs.
10)Transfusion treatment within 2 weeks prior to enrollment.
11)Moderate or large ascites or pleural effusion.
12)Continuous systemic steroid treatment.
13)Evidence of a psychological disorder that is judged to make it difficult to ensure the continuous use of the study drug.
14)Symptomatic evidence of known central nervous system metastases.
15)Daily treatment with atazanavir sulfate, which is incompatible with IRI.
16)Pregnant, possibly pregnant or breastfeeding, or unwilling to practice contraception during the study.
17)17) The patient registered other clinical studies in parallel
18)Any condition that suggests that the patient is, in the investigator's opinion, not an appropriate candidate for the study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taroh Satoh |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address
Yamadaoka 2-2, Suita, Osaka 565-0871, Japan
TEL
06-6879-2641
taroh@cfs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Sakai |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address
Yamadaoka 2-2, Suita, Osaka 565-0871, Japan
TEL
06-4790-7121
Homepage URL
dsakai@cfs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly
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
Address
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
| 2016 | Year | 07 | Month | 13 | 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
402
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
| 2016 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2024 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026585
