UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028170 |
|---|---|
| Receipt number | R000031754 |
| Scientific Title | S-1 and CPT-11 plus ramucirumab (IRIS+Rmab) as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer: A multicenter phase II study in Japan (N-DOCC-F-C-1701) |
| Date of disclosure of the study information | 2017/07/19 |
| Last modified on | 2019/04/29 14:48:57 |
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Basic information
Public title
S-1 and CPT-11 plus ramucirumab (IRIS+Rmab) as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer: A multicenter phase II study in Japan (N-DOCC-F-C-1701)
Acronym
Second-line IRIS+Rmab for mCRC (N-DOCC-F-C-1701)
Scientific Title
S-1 and CPT-11 plus ramucirumab (IRIS+Rmab) as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer: A multicenter phase II study in Japan (N-DOCC-F-C-1701)
Scientific Title:Acronym
Second-line IRIS+Rmab for mCRC (N-DOCC-F-C-1701)
Region
| Japan |
Condition
Condition
patients with advanced or recurrent colorectal cancer after failure or unfeasible L-OHP+5-FU regimen
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
review of safety and efficacy of IRIS+Rmab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
progrssion free survival (PFS)
Key secondary outcomes
response rate
over all survival (OS)
safety (adverse events)
quality of life (QOL) (1, 2 courses and end of trial)
review of nausea and vomiting for 1 through 3 courses
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
Treatment by IRIS+Rmab
Ramucirumab at a dose of 10mg/kg was administered as a
120-min infusion and irinotecan at a dose of 150mg/m2 by adjustment by
UGT1A1 was administered as a 90-min infusion every 3 weeks.
The dose of S-1 was determined according to the patient's body surface area (BSA). Specifically, the drug was administered orally twice daily for 14 consecutive days at a dose that did not exceed 40 mg/m2 based on BSA as follows-BSA<1.25m2, 40 mg; BSA 1.25-1.5 m2, 50mg twice daily; and BSA >1.5 m2, 60 mg by adjustment of Ccr. Premedication with a 5-HT3 antagonist combined with dexamethasone (+/-) an NK-1 antagonist was recommended in patients before the administration of irinotecan. This treatment was administered until disease progression, unacceptable toxicity, withdrawal of consent, or the physician's decision to terminate treatment.
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
All patients enter in this study such that
1) acquisition of written informed consent
2) the case whom investigators recognize appropriate
for joining this trial
3) having histologically confirmed advanced or
metastatic colorectal cancer
4) withdrawal from first-line oxaliplatin-based
chemotherapy because of intolerable toxicity or
progressive disease or relapse within 180 days after the last oxaliplatin-based adjuvant chemotherapy
5) past history of radiation for target lesion except for
palliative use (bone metastasis)
6) age > 20 years
7) Cooperative Oncology Group (ECOG) performance status of 0 or 1
8) having measurable lesion on the basis of the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
ver 1.1
9) tolerate oral intake
10) adequate bone marrow, hepatic, and renal function
that were satisfiied with the below
1) white blood cell count >3,000/mm3,< 12,000/mm3
2) ANC >3,000/mm3
3) platelet cell count >100,000/mm3
4) hemogulobin> 9.0g/dL
5) serum total bilirubin <1.5 UNL
6) AST< 2.5 UNL (in case of liver metastasis<5.0 UNL)
7) ALT< 2.5 UNL (in case of liver metastasis<5.0 UNL)
8) serum creatinine<1.5 UNL
9) urine protein: 0, +/-, 1+ or 2+ and Up/Uc<2.0
10) Ccr >= 30mL/min
11) UGT1A1 polymorphism: *6, *28 except for double
homo
12) estimated life expectancy of >3 months
Key exclusion criteria
Patients are excluded from this study for any of the
following reasons
1) severe complicationssuch as intestinal pneumonia, lung fibrosis, renal dysfunction, hepatic dysfunction, uncontrolled hypertension, severe diabetes mellitus requiring insulin
2) remarkably abnormal electrocardiogram, symptomtic heart disease (heart failure, myocardial infarction,angina)
3) symptomatic infectious disease, under or no treated HCV
4) symptomatic pleural effusion or ascites such as needing frequent puncture
5) past history of severe drug allergy
6) active double cancer
7) psychopathy, abnormal central nervous system, cerebrovascular disease
8) radiological evidence of brain tumor or brain metastases,
9) gastrointestinal ulcer, bleeding, obstruction, paralysis, perforation
10) obstructive bowel disease
11) watery diarrhea, or more than Grade2 diarrhea
12) past history of thrombosis or cerebral infarctinon except for asymptomatic lacunar infraction
13) congenital bleeding tendency,
14) need anti-coagulant drug except equivalent low-dose aspirin (<325mg)
15) need steroidal drug
16) need flucytosine or Atazanavir sulfuric acid
17) pregnancy, breast feeding
18) female patient hope for partner pregnancy
19) previous treatment with irinotecan hydrochloride
20) history of hemoptysis grade2, radiological
21) contraindication of S-1, CPT-11, ramucirumab
23) the case whom investigators recognize inappropriate for joining this trial
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuma Kobayashi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Surgery
Zip code
Address
1-7-1 Sakamoto Nabasaki-city, 852-8501, Japan
TEL
095-819-7316
kazuma-k2013@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuma Kobayashi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Surgery
Zip code
Address
1-7-1 Sakamoto Nabasaki-city, 852-8501, Japan
TEL
095-819-7316
Homepage URL
kazuma-k2013@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
No funding is received by any institutions
Organization
Division
Category of Funding Organization
Other
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
国立病院機構 長崎医療センター（長崎県）、長崎労災病院（長崎県）、国立病院機構 佐賀病院（佐賀県）、長崎記念病院（長崎県）、光晴会病院（長崎県）、光晴会病院（長崎県）、長崎みなとメディカルセンター（長崎県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 19 | 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
3
Results
First case :2018/03/26, Nagasaki University Hospital
Second case: 2018/11. KOUSEIKAI Hospital
Third case :2019/03/26, Nagasaki University Hospital
Results date posted
| 2019 | Year | 04 | Month | 29 | Day |
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
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
This trial has ended at 2019, March 31.
Management information
Registered date
| 2017 | Year | 07 | Month | 10 | Day |
Last modified on
| 2019 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031754
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