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Length of the Proximal Resection Margin for Siewert-II/Siewert-III Tumors

NCT02313688 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2017-12-11

No results posted yet for this study

Summary

The incidence of adenocarcinomas of the esophagogastric junction (AEJ) has increased rapidly during the past decades. By the Siewert classification, the AEJ is the tumor center located 5 cm above the anatomic cardia and 5 cm below it, which is divided into three individual subtypes. Complete tumor resection is the primary therapy strategies for tumors of the AEJ. The Japan Clinical Oncology Group 9502 (JCOG 9502) found that transabdominal or transhiatal approach gastrectomy has better survival outcomes compared with left thoracoabdominal approach surgery for Siewert II/III tumors. Transabdominal approach gastrectomy is recommended as the standard treatment strategy for Siewert II/III tumors by the guidelines of the Japanese Gastric Cancer Association (JGCA). However, the length of the proximal resection margin for Siewert-II/III tumors by transabdominal/transhiatal gastrectomy is still controversies. Previous study found that longer than 2cm proximal resection margin had better survival outcome than less than 2cm proximal resection margin for Siewert-II/III tumors. On the other sides, due to more advanced tumor stage of patients in China when compared with Japan and Korea. It is necessary to conduct a randomized control study to analyze the length of resection margin in advanced adenocarcinomas of esophagogastric junction.

Therefore, this study was aimed to include those Siewert II/III tumor patients in Gastrointestinal Surgery Department, West China Hospital, Sichuan University to analyze the relationship between the length of proximal resection margin and survival outcomes.

Conditions

  • Stomach Neoplasms
  • Siewert Type II Adenocarcinoma of Esophagogastric Junction
  • Recurrence
  • Siewert Type III Adenocarcinoma of Esophagogastric Junction

Interventions

PROCEDURE

gastrectomy

Transabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 3±0.5 cm lengthen proximal resection margin.

PROCEDURE

gastrectomy

Transabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 5±0.5 cm lengthen proximal resection margin.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Jian-Kun Hu, M.D. Ph.D. · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2020-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313688 on ClinicalTrials.gov