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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000286 |
Receipt No. | R000000366 |
Scientific Title | Phase II Study of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer |
Date of disclosure of the study information | 2005/11/18 |
Last modified on | 2008/04/22 |
Basic information | ||
Public title | Phase II Study of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer | |
Acronym | Phase II Study of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer | |
Scientific Title | Phase II Study of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer | |
Scientific Title:Acronym | Phase II Study of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer | |
Region |
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Condition | |||
Condition | 5-fluorouracil resistant advanced and recurrent Gastric Cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Effectiveness and the safety are examined of bi-weekly Paclitaxel (TAXOL)for fluorouracil resistant advanced and recurrent Gastric Cancer. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Response Rate |
Key secondary outcomes | Adverse events, OS, TTP |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | TXL 140mg/m2/week iv, day1.15 q 4weeks | |
Interventions/Control_2 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) With pathologically proven gastric cancer
2) ECOG performance status of 0-2 3) With at least one measurable lesion (RECIST) 4)Cases with previous treatment containing 5- fluorouracil, and was refractory or recurrent (limited to only 1 course and the interval was required for more than 2 weeks) 5) With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. 6) No Accompanied serious diseases, No Active secondary cancer 7) Age 20-80 years 8) With written informed consent |
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Key exclusion criteria | 1) Accompanied serious diseases
2) A past history of drug allergy 3) A past history of allergic reaction to polyoxy-ethilen oil 4) Acute inflammatory disease 5) Peripheral neuropathy 6) Pregnancy or breast feeding 7) Concomitant malignancy. It influences survival, adverse events 8) Symptomatic brain metastasis 9) hypersensitivity to alcohol |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kitazato Univercity East Hospital | ||||||
Division name | Digestive Internal Medicine | ||||||
Zip code | |||||||
Address | 2-1-1 Asamizodai Sagamihara-shi Kanagawa Japan | ||||||
TEL | |||||||
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Organization | The Tokyo Cooperative Oncology Group | ||||||
Division name | Secretariat | ||||||
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Sponsor | |
Institute | The Tokyo Cooperative Oncology Group |
Institute | |
Department |
Funding Source | |
Organization | The Tokyo Cooperative Oncology Group |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
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Baseline Characteristics | |
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Adverse events | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date trial data considered complete |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000366 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |