UMIN ID: C000000121
Registered date:06/09/2005
Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | gastric neoplasm |
| Date of first enrollment | 1995/07/01 |
| Target sample size | 520 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | A: Surgery:D2 dissection B: Surgery:D2+paraaortic dissection |
Outcome(s)
| Primary Outcome | overall survival |
|---|---|
| Secondary Outcome | relapse-free survival, operative morbidigy and mortality, length of postoperative hospital stay, quality of life |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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% |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) | NCT00149279 |
Contact
| public contact | |
| Name | Mitsuru Sasako, MD |
| Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 JAPAN Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG9501 Coordinating Office Gastric Surgery Division, National Cancer Center Hospital |
| scientific contact | |
| Name | Mitsuru Sasako, MD |
| Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 JAPAN Japan |
| Telephone | |
| Affiliation | National Cancer Center Hospital Gastric Surgery Division |