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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000308 |
Receipt No. | R000000398 |
Scientific Title | Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506) |
Date of disclosure of the study information | 2006/01/19 |
Last modified on | 2014/02/21 |
Basic information | ||
Public title | Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506) | |
Acronym | Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506) | |
Scientific Title | Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506) | |
Scientific Title:Acronym | Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506) | |
Region |
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Condition | ||
Condition | pancreatic neoplasm | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to evaluate safety and efficacy of a gemicitabin alone as a first-line treatment for locally advanced pancreatic cancer patients.
We plan a next phase III study to compare this regimen with chemoradiotherapy with fluorouracil. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | 1-year overall survival |
Key secondary outcomes | clinical benefit response (CBR), CA19-9 response, adverse events |
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 30-minute infusion of gemcitabine (1000 mg/m2/day, days 1, 8, and 15) every 4 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity. | |
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 | Patients are included if they meet the following criteria: histologically or cytologically proven exocrine pancreatic cancer, locally advanced: T4 (UICC) without obvious organ metastasis, aged 20 years or over, definitive chemoradiotherapy can be indicated: all pancreas lesions and lymph node metastases are included in the radiation field, 15 cm on a side, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2. In recurred cases, sufficient organ function. They have no history of radiotherapy, chemotherapy and surgery for pancreas except for exploraratory laparotomy, choledochojejunostomy and gastrojejunostomy. They provided written informed consent. | |||
Key exclusion criteria | Patients are excluded if they meet the following criteria: They have obvious ascetic or pleural effusion, lung fibrosis or pneumonitis, uncontrolled diabetes mellitus in spite of using more than 40 unit insulin, Classification of New York Heart Association (NYHA) of III or IV, myocardial infarction within 6 months before this trial, synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, or severe mental disease. | |||
Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyorin University School of Medicine | ||||||
Division name | Medical Oncology Division | ||||||
Zip code | |||||||
Address | 6-20-2,Shinkawa,Mitaka,Tokyo 181-8611,Japan | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | JCOG0506 Coordinating Office | ||||||
Division name | Medical Oncology Division, National Cancer Institute Hospital | ||||||
Zip code | |||||||
Address | 63-10-6,Ariake,Koto-ku,Tokyo 135-8550,Japan | ||||||
TEL | |||||||
Homepage URL | http://www.jcog.jp/ | ||||||
JCOG_sir@ml.jcog.jp |
Sponsor | |
Institute | Japan Clinical Oncology Group(JCOG) |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Health, Labour and Welfare |
Organization | |
Division | |
Category of Funding Organization | |
Nationality of Funding Organization | Japan |
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 | 北海道大学病院 (北海道)
岩手県立中央病院(岩手県) 山形県立中央病院(山形県) 茨城県立中央病院・茨城県地域がんセンター(茨城県) 栃木県立がんセンター(栃木県) 埼玉県立がんセンター(埼玉県) 国立がんセンター東病院 (千葉県) 総合病院国保旭中央病院 (千葉県) 国立がんセンター中央病院(東京都) 昭和大学病院(東京都) 神奈川県立がんセンター(神奈川県) 横浜市立市民病院(神奈川県) 横浜市立大学附属市民総合医療センター(神奈川県) 静岡県立静岡がんセンター(静岡県) 愛知県がんセンター中央病院(愛知県) 大阪市立総合医療センター(大阪府) 大阪医科大学(大阪府) 神戸大学医学部(兵庫県) 兵庫県立がんセンター(兵庫県) 国立病院機構四国がんセンター(愛媛県) 高知医療センター(高知県) |
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 | http://www.ncbi.nlm.nih.gov/pubmed/20185458 |
Number of participants that the trial has enrolled | |
Results | See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
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=R000000398 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |