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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004055
Receipt No. 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

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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
Institute Aichi Cancer Center Hospital
Institute
Department

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
URL(English) https://upload.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


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