UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025659 |
|---|---|
| Receipt number | R000029517 |
| Scientific Title | A multicenter, single-arm, phase II study of ramucirumab plus FOLFIRI with 150 mg/m2 irinotecan, standard Nippon dose, as the second-line treatment for Japanese patients with metastatic colorectal cancer |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/01/29 10:53:03 |
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Basic information
Public title
A multicenter, single-arm, phase II study of ramucirumab plus FOLFIRI with 150 mg/m2 irinotecan, standard Nippon dose, as the second-line treatment for Japanese patients with metastatic colorectal cancer
Acronym
Study rindo
Scientific Title
A multicenter, single-arm, phase II study of ramucirumab plus FOLFIRI with 150 mg/m2 irinotecan, standard Nippon dose, as the second-line treatment for Japanese patients with metastatic colorectal cancer
Scientific Title:Acronym
Study rindo
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objectives of this phase II study are to evaluate the efficacy and safety of FOLFIRI with low dose irinotecan (150 mg/m2, standard dose in Japan) plus ramucirumab (RAM) as a second-line treatment for Japanese patients with metastatic colorectal cancer (mCRC).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression-free survival (PFS)
Key secondary outcomes
Overall survival (OS), time to treatment failure (TTF), objective response rate (ORR), early tumor shrinkage (ETS), depth of response (DpR), two-dimensional response (2-DR), relative dose intensity (RDI) of irinotecan and ramucirumab, and incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FOLFIRI plus ramucirumab treatment
ramucirumab : administered intravenously at a dose of 8 mg/kg over 60 minutes on day 1.
l-leucovorin: administered intravenously at a dose of 200 mg/m2 over 120 minutes on day 1.
irinotecan: administered intravenously at a dose of 150 mg/m2 over 90 minutes on day 1.
bolus 5-fluorouracil: administered by rapid intravenous infusion at a dose of 400 mg/m2 on day 1.
infusional 5-fluorouracil: administered by continuous intravenous infusion at a dose of 2400 mg/m2 over 46 hours from days 1 to 3.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed colorectal adenocarcinoma.
2. Unresectable metastatic disease.
3. Age 20 to 80 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Prior oxaliplatin-based chemotherapy.
6. Prior bevacizumab or anti-EGFR containing regimen.
7. Bidimensionally measurable disease.
8. Adequate organ function.
9. The RAS mutation status (wild-type, mutant or not definable) of the patients is known prior to randomization.
10. Written informed consent was obtained.
Key exclusion criteria
1. Previous history of severe drug-induced allergy
2. Brain metastasis
3. Cerebrovascular disease or its symptoms within 1 year.
4. Massive pleural effusion or ascites that required drainage.
5. History of active double cancer.
6. Previous history of thoromboembolitic disease, or necessity for antithrombotic drug.
7. Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer.
8. History of gastrointestinal perforation within 1 year.
9. Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy.
10. Severe renal failure or urinary protein (more than 2+).
11. Uncontrolled severe complications (DM, hypertension, diarrhea, et al.).
12. Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated.
13. Interstitial lung disease or pulmonary fibrosis.
14. Uncontrolled infection.
15. Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week.
16. UGT1A1 gene status of homo type (*28/*28, *6/*6) or double hetero-type genetic polymorphisms *28 or *6 (*1/*28 and *1/*6).
17. Prior irinotecan or ramucirumab containing chemotherapy
18. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
19. Not appropriate for the study at the physician's assessment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goro Nakayama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65 Tsurumai-chi, Showa-ku, Nagoya, Japan
TEL
0527442250
goro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goro Nakayama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65 Tsurumai-chi, Showa-ku, Nagoya, Japan
TEL
0527442250
Homepage URL
goro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
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
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
| 2017 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 01 | Month | 13 | Day |
Last modified on
| 2018 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029517
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