UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004055
Receipt number R000004871
Scientific Title Randomized Phase II Study Comparing Dose Escalated Weekly Paclitaxel versus Standard Dose Weekly Paclitaxel for Patients with Previously Treated Advanced Gastric Cancer
Date of disclosure of the study information 2010/08/17
Last modified on 2014/02/17 21:02:32

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Basic information

Public title

Randomized Phase II Study Comparing Dose Escalated Weekly Paclitaxel versus Standard Dose Weekly Paclitaxel for Patients with Previously Treated Advanced Gastric Cancer

Acronym

Randomized Phase II Study Comparing Dose Escalated Weekly Paclitaxel versus Standard Dose Weekly Paclitaxel for AGC

Scientific Title

Randomized Phase II Study Comparing Dose Escalated Weekly Paclitaxel versus Standard Dose Weekly Paclitaxel for Patients with Previously Treated Advanced Gastric Cancer

Scientific Title:Acronym

Randomized Phase II Study Comparing Dose Escalated Weekly Paclitaxel versus Standard Dose Weekly Paclitaxel for AGC

Region

Japan


Condition

Condition

Previously Treated Advanced or Recurrent Gastric Cancer

Classification by specialty

Medicine in general Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of dose escalated weekly paclitaxel for the treatment of patients with advanced gastric cancer that has progressed after one or more previous chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

overall survival

Key secondary outcomes

progression free survival, response rate, disease control rate, duration of response, toxicity


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Standard Dose Weekly Paclitaxel

Interventions/Control_2

Dose Escalated 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 or cytologically proven gastric adenocarcinoma
2. Objectively or clinically progressed after one or more chemotherapy(including recurrence within 6 months after last adjuvant chemotherapy)
3. Age 20 or older
4. ECOG PS 0-2
5. Having Evaluable disease
6. No history of taxanes chemotherapy
7. Fulfill following laboratory data
Leucocyte count 3000/mm3 or more
Neutrophil count 1500/mm3 or more
Platelet count 10.0x104/mm3 or more
Hemoglobin level 8.0 g/dL or more
Total Bilirubin 1.5 mg/dL or less
AST,ALT 100IU/L or less (200IU/L if with liver metastases)
Creatinine <2.0mg/dl
8. Life expectancy 8 weeks or more
9. Written informed consent from patient

Key exclusion criteria

1. Alcohol intolerance
2. Symptomatic brain metastasis
3. Paralytic or mechanical bowel obstruction
4. Watery diarrhea
5. Uncontrolled ascites or pleural effusions
6. Confirmed or suspected infection
7. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysematous)
8. Severe comorbidities (uncontrollable diabetes, heart failure with NYHA III or IV, renal failure, liver failure)
9. Pregnant woman, lactating woman
10. Sever neurologic disease
11. Grade2 or more neuropathy
12. HIV infection

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kohei Shitara

Organization

Aichi Cancer Center Hospital

Division name

Department of Clinical Oncology

Zip code


Address

1-1 Kanokoden, Chikusa-ku, Nagoya

TEL

04-7133-1111

Email

kouheis0824@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name shitara kohei

Organization

Aichi Cancer Center Hospital

Division name

Department of Clinical Oncology

Zip code


Address

1-1 Kanokoden, Chikusa-ku, Nagoya

TEL

04-7133-1111

Homepage URL


Email

kouheis0824@yahoo.co.jp


Sponsor or person

Institute

Aichi Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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


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



Other administrative information

Date of disclosure of the study information

2010 Year 08 Month 17 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

2010 Year 07 Month 02 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 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

2010 Year 08 Month 17 Day

Last modified on

2014 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004871


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name