UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009297
Receipt number 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 2023/01/10 09:39:38

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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 or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2012 Year 10 Month 20 Day

Date of IRB

2012 Year 10 Month 25 Day

Anticipated trial start date

2012 Year 12 Month 03 Day

Last follow-up date

2017 Year 10 Month 03 Day

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

2023 Year 01 Month 10 Day



Link to view the page

Value
https://center6.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