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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028170
Receipt No. 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

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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
Email 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
Email kazuma-k2013@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences, Department of Surgery
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031754

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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