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Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501)

Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501) - Randomized controlled trial to evaluate para-aortic lymphadenectomy for gastric cancer (JCOG9501)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000121
Enrollment
520
Registered
2005-09-06
Start date
1995-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric neoplasm

Interventions

A: Surgery:D2 dissection B: Surgery:D2+paraaortic dissection

Sponsors

Japan Clinical Oncology Group(JCOG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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%

Design outcomes

Primary

MeasureTime frame
overall survival

Secondary

MeasureTime frame
relapse-free survival, operative morbidigy and mortality, length of postoperative hospital stay, quality of life

Countries

Japan

Contacts

Public ContactMitsuru Sasako, MD

JCOG9501 Coordinating Office Gastric Surgery Division, National Cancer Center Hospital

JCOG_sir@ml.jcog.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026