UMIN-CTR Clinical Trial

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
Email	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
Email	yi-nakamu@umin.ac.jp

Sponsor
Institute	Nagasaki Thoracic Oncology Group
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007725