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
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
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
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
