UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006514 |
|---|---|
| Receipt number | R000007725 |
| Scientific Title | Phase II trial of irinotecan, paclitaxel plus bevacizumab for previously untreated patients with non-squamous and non-small cell lung cancer, detected the over-expression of ERCC1 by EBUS-GS. |
| Date of disclosure of the study information | 2011/10/12 |
| Last modified on | 2022/06/09 16:32:32 |
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Basic information
Public title
Phase II trial of irinotecan, paclitaxel plus bevacizumab for previously untreated patients with non-squamous and non-small cell lung cancer, detected the over-expression of ERCC1 by EBUS-GS.
Acronym
Phase II trial of irinotecan, paclitaxel plus bevacizumab for patients with NSCLC
Scientific Title
Phase II trial of irinotecan, paclitaxel plus bevacizumab for previously untreated patients with non-squamous and non-small cell lung cancer, detected the over-expression of ERCC1 by EBUS-GS.
Scientific Title:Acronym
Phase II trial of irinotecan, paclitaxel plus bevacizumab for patients with NSCLC
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
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
irinotecan 50mg/m2
paclitaxel 180mg/m2
bevacizumab 15mg/kg
every 4weeks more than 3cycles
maintenance of bevacizumab until PD
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)non-squamou and non-small cell lung cancer with over-expression of ERCC1
2)not having homo-UGT1A1*6 and *28
3)stage IIIB or IV without indication of radiation
4)previously untreated patients without EGFR-TKIs
5)ECOG PS 0-1
6)having measurable lesions according to RECIST(version1.1)
7)adequate kidney, liver, bone marrow functions
8)expecting the survival period more than 12 weeks
9)written informed consent
Key exclusion criteria
1)brain metastasis
2)cavity lesion
3)invasion of giant vessels
4)hemoptysis
5)history of radiotherapy for lung
6)interstitial pneumonitis
7)watery diarrhea
8)severe gastrointestinal disease
9)uncontrollable fever up
10)other sever disease
11)uncontrollable pericardial,pleural effusion and ascites
12)other carcinoma
13)sever allergy history
14)receiving anti-coagulate treatment without biaspilin
15)psychological disease
16)women with pregnant or under lactation
17)others diagnosed as inadequate case to enter the trial
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Nakamura |
Organization
Nagasaki University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7273
yi-nakamu@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Nakamura |
Organization
Nagasaki University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7273
Homepage URL
yi-nakamu@umin.ac.jp
Sponsor or person
Institute
Nagasaki Thoracic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
NEOCI
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.jp
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
| 2011 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6397920/
Number of participants that the trial has enrolled
12
Results
The triplet combination might be effective for patients with advanced, untreated NSCLC overexpressing ERCC1. ERCC1 messenger RNA levels may be a predictive factor for response to platinum-containing regimens.
Results date posted
| 2022 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Untreated advanced non-small cell lung cancer, who has good performance status and adequate organs functions.
Participant flow
Patients were diagnosed with NSCLC using endobronchial ultrasonography with a guide sheath as a core biopsy. RNA was immediately isolated from unfixed biopsy specimens, and quantitative real-time reverse transcription-PCR assays were performed to determine ERCC1 messenger RNA expression. Patients with advanced, untreated NSCLC showing high ERCC1 levels were assigned a non-platinum triplet regimen of irinotecan and paclitaxel plus bevacizumab.
Adverse events
Neutropenia was the most common grade 3/4 adverse event and occurred in 47% (14/30) of patients. Other grade 3/4 hematological toxicities included leukopenia (27%, 8/30) and anemia (3%, 1/30). Grade 3/4 non-hematological toxicities included febrile neutropenia (23%, 7/30), hypertension (7%, 2/30), duodenal ulcer, ileus, bleeding, thrombosis, pneumonitis, increased alanine transaminase and aspartate transaminase levels (3%, 1/30 each). No treatment-related death occurred.
Outcome measures
Objective response rate 66.7%
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 10 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007725
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