A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-07-31

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Spleen-Preserving No. 10 Lymph Node Dissection in Gastric Cancer

NCT04050787

Overall Survival

UNKNOWN NA

3D Versus 2D Laparoscopic Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection

NCT02984787

Splenic Hilum Lymph Nodes Dissection

UNKNOWN PHASE3

Robotic Total Gastrectomy for Locally Advanced Proximal Gastric Cancer

NCT03524287

Stomach Neoplasms

COMPLETED NA

Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by UFT in Serosa-positive Gastric Cancer (JCOG9206-2)

NCT00147147

Gastric Neoplasm

COMPLETED PHASE3

Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer

NCT03961373

Locally Advanced Gastric Cancer

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Radical gastrectomy with regional lymphadenectomy is the only curative treatment option for gastric cancer. The extent of lymphadenectomy, however, is controversial. The two European randomized trials only reported an increase in operative morbidity and mortality, but failed to show survival benefit, in the D2 lymphadenectomy group. We conducted a randomized controlled trial to compare the Japanese standard D2 and D2 + para-aortic nodal dissection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgery: D2 dissection

Intervention Type PROCEDURE

Surgery: D2+paraaortic dissection

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No