Laparoscopic vs. Open Distal Gastrectomy After Neoadjuvant Chemotherapy

NCT04658589 | Not Yet Recruiting DMC

• 1 other identifier: H2020-0407
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study was designed as single-country, multi-center, open-labelled, randomized (1:1), phase II trial. 238 patients with medically and technically operable advanced gastric adenocarcinoma in middle or distal 1/3 of stomach are enrolled and randomly assigned to laparoscopic gastrectomy group and open gastrectomy group. 4 cycles of mFLOT chemotherapy will be conducted before and after gastrectomy. The primary objective of this study is comparison of D2 lymph node dissection compliance rate between open surgery group and laparoscopic surgery group after neoadjuvant chemotherapy.

Conditions

Stomach Neoplasm

Outcome Measures

Primary Outcomes (1)

• Number of harvested lymph nodes in D2 lymph node dissection

  number of lymph nodes, pathologically proven after surgery

  2 weeks after operation when the pathologic report is available

Secondary Outcomes (5)

• 3 year progression free survival

  3 years after randomization

• 3 year relapse free survival

  3 years after randomization

• Comparison of postoperative morbidity and mortality

  90 days after operation

• Curative resection rate

  2 weeks after operation when the pathologic report is available

• Conversion to open surgery

  1 day

Study Arms (2)

Laparoscopic distal gastrectomy

EXPERIMENTAL

Laparoscopic distal gastrectomy after neoadjuvant chemotherapy for the treatment of locally advanced gastric cancer patients

Procedure: Laparoscopic versus open distal gastrectomy

Open distal gastrectomy

ACTIVE COMPARATOR

Open distal gastrectomy after neoadjuvant chemotherapy for the treatment of locally advanced gastric cancer patients

Procedure: Laparoscopic versus open distal gastrectomy

Interventions

Laparoscopic versus open distal gastrectomy PROCEDURE

Laparoscopic versus open distal gastrectomy after neoadjuvant chemotherapy for locally advanced gastric cancer

Laparoscopic distal gastrectomy; Open distal gastrectomy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who voluntarily expressed their consent to participate in this trial by signing a written 'Subject Consent Form.'
• Patients whose gastric adenocarcinoma located in the middle or lower part of the stomach is histologically confirmed and deemed possible to perform a radical distal gastrectomy surgery.
• Patients who come under T2/N(+)M0, T3\~4a/N(- or +) M0 according to the 8th edition of the TNM classification.

You may not qualify if:

• Methodologies
• Patients less than 20 years old or older than 80 years old
• Eastern Cooperative Oncology Group(ECOG) ≥ 2
• Patients with a surgery experience due to a neoplasm in the stomach.
• Patients with complications due to gastric cancer (acute hemorrhage, gastric outlet obstruction or perforation)
• Patients with distant metastases (M1) including distant lymph nodes (Retropancreatic, para-aortic, periportal, retroperitoneal, or mesenteric lymph nodes)
• Patients without distant metastases but who are, according to a surgeon's judgment, unqualified for radical gastrectomy because of invasions to adjacent organs (T4b).
• In the case of localized conglomerated metastatic lymph nodes
• Patients who received surgery or radiation therapy for a primary cancer developed in another organ or those with active/synchronous double cancer in recent 5 years.
• Patients who participated in another clinical trial or was administered with a different investigational drug in 30 days prior to randomization.
• Patients who had any of the following in 6 months before the trial recruitment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass surgery, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
• Patients with a previous experience of uncontrolled seizure, central nervous system or psychological disorders whose conditions are clinically significant to the extent that they are unable to express consent to participate in the trial and oral drug administration is not possible.
• Patients with uncontrolled active infection or sepsis.
• Patients who had deep vein thrombosis in recent 4 weeks before the beginning of the trial recruitment.
• Patients with serious acute or chronic disease that can degrade the patient's ability to participate in the trial or impede the interpretation of the trial results.

Sponsors & Collaborators

• Chonnam National University Hospital: lead

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Young-Kyu Park, MD

CONTACT

+82-10-7173-1196; parkyk@jnu.ac.kr

Joong-Min Park, MD

CONTACT

jmpark@cau.ac.kr

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: Professor

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share