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CompletedNCT00149279Updated Sep 22, 2016

A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

A Phase 3 interventional study of Surgery: D2 dissection and Surgery: D2+paraaortic dissection in Gastric Neoplasm, sponsored by Japan Clinical Oncology Group. Completed at 1 site in Japan. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2016-09-22.

Sponsored by Japan Clinical Oncology Group · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
520
Allocation
Randomized
Ages
Up to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

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Conditions studied

  • Gastric Neoplasm

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Keywords

  • stomach neoplasms
  • lymph node excision
  • abdominal aorta
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In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 520 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Japan Clinical Oncology Group is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
520 participants

Interventions

  • ProcedureSurgery: D2 dissection
  • ProcedureSurgery: D2+paraaortic dissection
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What researchers measure

Primary outcomes

  1. overall survival

Secondary outcomes

  1. relapse-free survival

  2. operative morbidity and mortality

  3. length of postoperative hospital stay

  4. quality of life

07

Study locations

1 site
  • National Cancer Center Hospital
    Chuo-ku, Tokyo 104-0045, Japan
08

References and documents

Publications

  • Sano 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. PubMed 15199090 ↗
  • Kurokawa 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. PubMed 21104822 ↗
  • Sasako 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. PubMed 18669424 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00149279
Lead sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan
First posted
Sep 8, 2005
Start date
Jul 1995
Completion
Apr 2006
Last update
Sep 22, 2016

Study contacts

Mitsuru Sasako, MD
study chair · Gastric Surgery Division, National Cancer Center Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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