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

NCT02313688 | Unknown DMC

• 1 other identifier: WCH-GC-02
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

adenocarcinomas of esophagogastric junction; resection margin; length; prognosis

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival

  3 years

Secondary Outcomes (3)

• 3-year overall survival

  3 years

• Recurrence type

  3 years

• The positive rate of proximal resection margin

  Intraoperative

Study Arms (2)

Group A

EXPERIMENTAL

Group A: Patients in the Group A will underwent D2 total gastrectomy and with 3±0.5 cm lengthen proximal resection margin. Intraoperative frozen section will routinely performed to secure the tumor free resection margin.

Procedure: gastrectomy

Group B

EXPERIMENTAL

Patients in the Group B will underwent D2 total gastrectomy and with 5±0.5 cm lengthen proximal resection margin. Intraoperative frozen section will routinely performed to secure the tumor free resection margin.

Procedure: gastrectomy

Interventions

gastrectomy PROCEDURE

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

Group A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Preoperative endoscopy and biopsy confirmed upper third gastric adenocarcinoma (Siewert-II/Siewert-III), and predictively feasible of radical total gastrectomy;
• Predictively resectable diseases, advanced gastric cancer, of preoperative staging JGCA 14th Edition cT2N0M0-T4aN3bM0, Ib-IIIc stage;
• Age：≤75 years, or ≥18 years;
• Without serious disease and malignance disease;
• WHO performance score ≤2, ASA score ≤3;
• No limit to sexual and race;
• Informed consent required.

You may not qualify if:

• Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc;
• Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
• Severity mental diseases;
• Primary lesion cannot be resected in the pattern of transabdominal proximal gastrectomy, but for total gastrectomy, Whipple's procedure, or combined organ resection or with a transthoracic approach surgery;
• After signature the Clinical trial agreement, patients and their agent will quit the trial.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Recurrence; Margins of Excision

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jian-Kun Hu, M.D. Ph.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Han Zhang, M.D.

CONTACT

weihanwch@126.com

Xin-Zu Chen, M.D.

CONTACT

chen_xz_wch_scu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Gastrointestinal Surgery Department.

Study Record Dates

• First Submitted: December 7, 2014
• First Posted: December 10, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2023
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

CN (1)