Clinical trial · Interventional
A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer
Randomized Controlled Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer (JCOG9501)
NCT00149279CI-TRIAL-00023980completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Neoplasm | Gastric Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery: D2 dissection | Procedure | — | UNRESOLVED |
| Surgery: D2+paraaortic dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- overall survival
Secondary outcomes (4)
- measure
- relapse-free survival
- measure
- operative morbidity and mortality
- measure
- length of postoperative hospital stay
- measure
- quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
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. Macroscopic 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 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%
References
Publications (3)
- BACKGROUNDSano T, Sasako M, Yamamoto S, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K. Gastric cancer surgery: morbidity and mortality results from a prospective randomized controlled trial comparing D2 and extended para-aortic lymphadenectomy--Japan Clinical Oncology Group study 9501. J Clin Oncol. 2004 Jul 15;22(14):2767-73. doi: 10.1200/JCO.2004.10.184. Epub 2004 Jun 15. PMID 15199090
- DERIVEDKurokawa Y, Sasako M, Sano T, Shibata T, Ito S, Nashimoto A, Kurita A, Kinoshita T; Japan Clinical Oncology Group. Functional outcomes after extended surgery for gastric cancer. Br J Surg. 2011 Feb;98(2):239-45. doi: 10.1002/bjs.7297. PMID 21104822
- DERIVEDSasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035. PMID 18669424