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Laparoscopic vs. Open Distal Gastrectomy After Neoadjuvant Chemotherapy

ConditionStomach Neoplasm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChonnam National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic versus open distal gastrectomy

    Procedure/Surgery

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

Treatment groups

238 Participants
are divided into 2 treatment groups
Group A: Laparoscopic distal gastrectomyExperimental treatment 1 intervention
Group B: Open distal gastrectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of harvested lymph nodes in D2 lymph node dissection

number of lymph nodes, pathologically proven after surgery

Time frame
2 weeks after operation when the pathologic report is available

Secondary outcomes

1

3 year progression free survival

PFS is defined as time from the point of randomization to objective tumor progression or relapse, or to death according to RECIST 1.1.

Time frame
3 years after randomization
2

3 year relapse free survival

RFS is defined as time from the point of randomization to tumor relapse or death

Time frame
3 years after randomization
3

Comparison of postoperative morbidity and mortality

Defined as the incidence of complications within 30 days after surgery, death rate within 90 days. Classification and severity of the complications shall be based on that of KLASS-02-RCT.

Time frame
90 days after operation
4

Curative resection rate

Defined as a case where complete removal of all tumors were confirmed through gross or microscopic examination; negative resection margin was obtained; and, D2 lymph node dissection was performed.

Time frame
2 weeks after operation when the pathologic report is available

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chonnam National University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: