UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023026 |
|---|---|
| Receipt number | R000026538 |
| Scientific Title | Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/03/26 13:19:59 |
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Basic information
Public title
Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer
Acronym
Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer
Scientific Title
Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer
Scientific Title:Acronym
Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival (PFS)
Key secondary outcomes
early tumor shrinkage(ETS) rate
PFS of ETS positive and negative
depth of response(DpR)
Time to DpR
time to treatment failure(TTF)
response rate
overall survival
safety
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
ETS was defined as 20% or more tumor reduction at 8 weeks. Patients with ETS after 8 weeks from the treatment start date continued FOLFIRI + Cmab as induction to 16 weeks, and switched to FOLFIRI +BV for maintenance of progressive disease. Patients without ETS at 8 weeks immediately switched to FOLFIRI+BV to control progression.
FOLFIRI+Cmab induction therapy; Cetuximab: 250mg/m2day1 day1, 8(1cours day1:400mg/m2), CPT-11: 180mg/m2 day1, l-LV: 200mg/m2 day1, 5-FU bolus: 400mg/m2 day1, 5-FU infusion: 2400mg/m2 day1-2
FOLFIRI+BV maintenance therapy; Bevacizumab: 5mg/kg day1, CPT-11: 180mg/m2 day1, l-LV: 200mg/m2 day1, 5-FU bolus: 400mg/m2 day1, 5-FU infusion: 2400mg/m2 day1-2
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) Histologically proven adenocarcinoma of colorectal cancer
2) Unresectable/recurrence colorectal cancer, no prior chemotherapy
3) RAS wild type
4) >= 20 years old
5) Measurable lesion according to RECIST (Ver.1.1)
6) ECOG performance status (PS) 0-2
7) Adequate organ function
8) Life expectancy of more than 90 days
9) Written informed consent
Key exclusion criteria
1) Previous treatment with irinotecan, bevacizumab, cetuximab/panitumumab
2) Symptomatic brain metastasis
3) Intestinal paralysis/obstruction
4) Massive pleural effusion, ascites, or pericardial effusion
5) Uncontrolled diarrhea
6) Active synchronous or metachronous malignancy
7) Severe infectious disease
8) Grade2 or higher skin toxicity
9) Interstitial pneumonia or pulmonary fibrosis
10) Serious complication(uncontrolled diabetes, severe cardiac disease, renal failure, liver failure)
11) History of thromboembolism
12) Unhealed wounds
13) Previous treatment with radiotherapy for primary disease
14) Administration of aspirin
15) Carcinomatous meningitis, uncontrolled epilepsy, mental disorder
16) Systemic administration of steroid
17) History of severe allergy
18) Positive for HBs antigen
19) Women who are pregnant or patients who are unwilling to avoid pregnancy
20) Patients who are inappropriate for the study in the opinion of the investigator
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takako Eguchi Nakajima |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
Address
2-16-1 sugao miyamae-ku kawasaki kanagawa
TEL
044-977-8111
tnakajima@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Tsuda |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
Address
2-16-1 sugao miyamae-ku kawasaki kanagawa
TEL
044-977-8111
Homepage URL
tatsuda@marianna-u.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Oncology, St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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 | 08 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 05 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026538
