UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000015431 |
| Receipt No. | R000017946 |
| Scientific Title | Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer. |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2019/04/18 (Ver. 6) |
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| Basic information | ||
| Public title | Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer. | |
| Acronym | Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer. | |
| Scientific Title | Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer. | |
| Scientific Title:Acronym | Phase II trial of a low dose nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer. | |
| Region |
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| Condition | ||
| Condition | unrecectable or recurrent advanced gastric cancer | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To evaluate the safty and effectivity of low dose nab-paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer. |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Phase II |
| Assessment | |
| Primary outcomes | Response rate |
| Key secondary outcomes | Overall survival(OS),Progression free survival(PFS),Safty, Time to progression(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 | Patients receive 180mg of nab-paclitaxel per square meter of body-surface area on day 1 of every 21-day cycle. The patients continue therapy until disease progression or prohibitive toxic effects occure. | |
| Interventions/Control_2 | ||
| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | 1.Unresectable or recurrent advanced gastric cancer
2.Histologically confirmed adenocarcinoma, signet ring cell caricinoma and mucinous adenocarinoma. 3.Prior treatment by chemothrapy including 5-FU regimen 4.No central nurve metastasis 5.Age from 20 to 65 years old 6.Performance status is 0,1,2. 7.Required baseline laboratory data.(within 14 days of registration) Neu 1,500mm3 PLT 100,000mm3 T-Bil 1.5mgdL AST 100IU/L ALT 100IU/L serum creatine 1.5mg/dL 8.Expected survival time more than 90 days 9.The patient has previously given written, informed consent to participate in this study |
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| Key exclusion criteria | 1.With history of receiving paclitaxel treatment
2.With serious drug allergy 3.With servaral comorbid disease poorly controlled diabetes poorly controlled hypertension liver cirrhosis, liver failure renal failure intestitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema active infectious disease heart failure, myocardial infarction, angina pectoris or ECG abnormalities within 6 months 4.With active anothor cancer 5.With peripheral neuropathy greater than grade2 6.With HBs antigen positive 7.With pregnant or nursing women 8.Cases who physician judged improper to entry this trial |
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| Target sample size | 45 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| Organization | Yokohama City University Hospital | ||||||
| Division name | gastroenterological surgery | ||||||
| Zip code | |||||||
| Address | 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan | ||||||
| TEL | 045-787-2800 | ||||||
| endoit@med.yokohama-cu.ac.jp | |||||||
| Public contact | |||||||
| 1st name of contact person |
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| Organization | Yokohama City University Medical Center | ||||||
| Division name | Gastroenerological Center | ||||||
| Zip code | |||||||
| Address | 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan | ||||||
| TEL | 045-261-5656 | ||||||
| Homepage URL | |||||||
| rtakagawa@gmail.com | |||||||
| Sponsor | |
| Institute | Yokohama City University Medical Center |
| 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 | |
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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 | 横浜市立大学附属市民総合医療センター（神奈川県）
横浜市立大学附属病院（神奈川県） 横須賀共済病院（神奈川県） 横浜市立市民病院（神奈川県） 藤沢市民病院（神奈川県） 済生会横浜市南部病院（神奈川県） 独立行政法人国立病院機構横浜医療センター（神奈川県） 横浜みなと赤十字病院（神奈川県） 横浜保土ヶ谷中央病院（神奈川県） 横須賀市立市民病院（神奈川県） 伊東市民病院（神奈川県） NTT東日本関東病院（神奈川県） 済生会若草病院（神奈川県） 横浜掖済会病院（神奈川県） 長津田厚生総合病院（神奈川県） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | |||||||
| Number of participants that the trial has enrolled | 34 | ||||||
| Results | Anticancer Res. 2018 Dec;38(12):6911-6917. doi: 10.21873/anticanres.13068. |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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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=R000017946 |
