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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000121 |
Receipt No. | R000000175 |
Scientific Title | Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501) |
Date of disclosure of the study information | 2005/09/06 |
Last modified on | 2014/02/21 |
Basic information | ||
Public title | Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501) | |
Acronym | Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501) | |
Scientific Title | Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501) | |
Scientific Title:Acronym | Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501) | |
Region |
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Condition | ||
Condition | gastric neoplasm | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | overall survival |
Key secondary outcomes | relapse-free survival, operative morbidigy and mortality, length of postoperative hospital stay, quality of life |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | NO |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | A: Surgery:D2 dissection | |
Interventions/Control_2 | B: Surgery:D2+paraaortic dissection | |
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 | Preoperatively,
(1) histologically proven adenocarcinoma (2) 75 years old or younger (3) forced expiratory volume in one second ≥ 50 % (4) arterial oxygen pressure in room air ≥ 70 mmHg (5) creatinine clearance ≥ 50 ml/min (6) written consent. Intraoperatively (7) mMacroscopic T staging is T2-subserosa, T3, or T4 (8) potentially curative operation is possible (9) no gross metastasis in para-aortic nodes (frozen section diagnosis not allowed) (10) peritoneal lavage cytology is negative for cancer cells |
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Key exclusion criteria | (1) Carcinoma in the remnant stomach
(2) Borrmann type 4 (linitis plastica) (3) synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma (4) past history of myocardial infarction or positive results of exercise ECG (5) liver cirrhosis, or chronic liver disease with indocyanine green test ≥10% |
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Target sample size | 520 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cancer Center Hospital | ||||||
Division name | Gastric Surgery Division | ||||||
Zip code | |||||||
Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 JAPAN | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | JCOG9501 Coordinating Office | ||||||
Division name | Gastric Surgery Division, National Cancer Center Hospital | ||||||
Zip code | |||||||
Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 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 | YES |
Study ID_1 | NCT00149279 |
Org. issuing International ID_1 | ClinicalTrials.gov by NLM |
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 | Published |
Result | |
URL related to results and publications | http://www.ncbi.nlm.nih.gov/pubmed/18669424 |
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 |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | A part of the results were published in J Clin Oncol 22:2767-2773. |
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=R000000175 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |