UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009297
Receipt No. R000010909
Scientific Title Randomized phase II study comparing trastuzumab plus weekly paclitaxel with weekly paclitaxel alone for patients with HER2-positive advanced gastric or gastro-esophageal junction cancer refractory to trastuzumab combined with fluoropyrimidine and platinum.
Date of disclosure of the study information 2012/11/09
Last modified on 2018/11/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized phase II study comparing trastuzumab plus weekly paclitaxel with weekly paclitaxel alone for patients with HER2-positive advanced gastric or gastro-esophageal junction cancer refractory to trastuzumab combined with fluoropyrimidine and platinum.
Acronym Trial to Assess the Concept of using Trastuzumab beyond progression
Scientific Title Randomized phase II study comparing trastuzumab plus weekly paclitaxel with weekly paclitaxel alone for patients with HER2-positive advanced gastric or gastro-esophageal junction cancer refractory to trastuzumab combined with fluoropyrimidine and platinum.
Scientific Title:Acronym Trial to Assess the Concept of using Trastuzumab beyond progression
Region
Japan

Condition
Condition gastric or gastro-esophageal junction adenocarcinoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of trastuzumab + paclitaxel compared with paclitaxel alone in HER2-positive advanced gastric and gastro-esophageal junction adenocarcinoma patients refractory to trastuzumab + fluoropyrimidine + platinum containing chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Overall survival, time to treatment failure, overall response rate, disease control rate, safety and translational biomarker research

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 weekly paclitaxel
Interventions/Control_2 trastuzumab + weekly paclitaxel
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 advanced unresectable or recurrent gastric or gastro-esophageal junction adenocarcinoma
2) Her2 positive (IHC3+ or ICH2+/FISH >=2.0)
3) Measurable or evaluable lesion
4) No previous chemotherapy nor radiation therapy for malignant tumor except for gastric cancer.
5) Refractory to fluoropyrimidine , platinum and trastuzumab containing chemotherapy.
6) Prior trastuzumab therapy with more than three doses, and within 6 weeks from last trastuzumab administration.
7) No prior therapy with taxan.
8) No prior therapy with anti-HER2 drugs except trastuzumab
9) No ileus or sub-ileus
10) ECOG performance status 0-2.
11) Expected survival >= 90 days.
12) Adequate bone marrow and organ function as defined as below:
leukocyte count >=3000/mm3
neutrophil count >=1500/mm3
hemoglobin level >= 8.0 g/dL
platelet count >= 100,000/mm3
AST and ALT <= 100 IU/L, or AST and ALT <=200 IU/L with liver metastases
total bilirubin <= 1.5 mg/dL
serum creatinine <=2.0 mg/dL
13) Left Ventricular Ejection Fraction (LVEF) >=50% measured by echocardiography or multi-gated acquisition scan (MUGA)
14) Written informed consent
Key exclusion criteria 1) Discontinuation of trastuzumab due to adverse event.
2) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma.
3) Evidence of any other serious disease, e.g. active gastrointestinal hemorrhage, uncontrolled cardiovascular disease and uncontrolled diabetes mellitus.
4) Active infection under treatment.
5) History of serious allergic reactions.
6) Pulmonary fibrosis or interstitial pneumonitis detected by chest x-ray.
7) Symptomatic brain metastases or carcinomatous meningitis.
8) Massive pericardial effusion, pleural effusion or ascites*.
*except for patients if effusions and ascites did no accumulate for more than two weeks after dranage therapy.
*include patients if pleurosclerosis was performed with anti-cancer drugs except OK-432.
9) Peripheral sensory neuropathy of grade >= 2 according to NCI-CTCAE version 4.0.
10) Current treatment with corticosteroids.
11) Blood tests positive for HBs antigen.
12) Active gastrointestinal hemorrhage requiring multiple blood transfusions.
13) Uncontrolled psychiatry disease.
14) Pregnant or lactating female.
15) Judged inappropriate by the investigators.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akitaka Makiyama
Organization JCHO Kyushu hospital
Division name Department of Hematology/Oncology
Zip code
Address 1-8-1 Kishinoura, Yahatanishi-ku Kitakyushu-city, Fukuoka 806-8501, Japan
TEL 093-641-5111
Email makiyama20@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization Japan Society of Clinical Oncology
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 千葉県がんセンター(千葉県)、大阪府立急性期・総合医療センター(大阪府)、兵庫県立がんセンター(兵庫県)、虎の門病院(東京都)、大阪府立成人病センター(大阪府)、九州がんセンター(福岡県)、大阪市立総合医療センター(大阪府)、聖マリアンナ医科大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2012 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 09 Day
Last modified on
2018 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010909

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.