NCT00147147

Brief Summary

To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or greater lymph node dissection in T3-4 gastric cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 1993

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1993

Completed
11.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

First QC Date

September 5, 2005

Last Update Submit

September 20, 2016

Conditions

Gastric Neoplasm

Keywords

gastric neoplasmgastrectomyadjuvant chemotherapyrandomized trialT3 and T4 carcinoma of the stomach/Gastric Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (2)

  • Relapse-free survival

  • the site of recurrence

Interventions

Gastrectomy with D2 or greater lymph node dissectionPROCEDURE
Gastrectomy+ chemotherapyDRUG

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Curative operation with D2 or greater lymph node dissection
  • Histologically proven gastric adenocarcinoma
  • Macroscopically serosa-positive (T3-4)
  • No metastases to level 3 - 4 lymph nodes station (N0-2)
  • years or younger
  • Negative peritoneal lavage cytology
  • Adequate organ function WBC \>=4000/mm3,Hb \>=11.0g/dl,Plt \>=100.000/mm3,AST/ALT, T.Bil, BUN, Creatinine \<=2.5 x Normal Upper Limit,Creatinine clearance \<=70 ml/min
  • Written informed consent

You may not qualify if:

  • Prior chemotherapy or radiotherapy
  • Synchronous or metachronous malignancy in other organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastric Surgery Division, National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Related Publications (1)

  • Miyashiro I, Furukawa H, Sasako M, Yamamoto S, Nashimoto A, Nakajima T, Kinoshita T, Kobayashi O, Arai K; Gastric Cancer Surgical Study Group in the Japan Clinical Oncology Group. Randomized clinical trial of adjuvant chemotherapy with intraperitoneal and intravenous cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer versus curative resection alone: final results of the Japan Clinical Oncology Group trial JCOG9206-2. Gastric Cancer. 2011 Aug;14(3):212-8. doi: 10.1007/s10120-011-0027-3. Epub 2011 Feb 19.

    PMID: 21336855DERIVED

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Hiroshi Furukawa, MD, PhD

    Sakai Municipal Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2005

First Posted

September 7, 2005

Study Start

January 1, 1993

Study Completion

March 1, 2004

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

JP(1)