Stomach NeoplasmNCT04658589
Laparoscopic vs. Open Distal Gastrectomy After Neoadjuvant Chemotherapy
A study testing Laparoscopic versus open distal gastrectomy in people with Stomach Neoplasm, run by Chonnam National University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stomach Neoplasm
- What is being tested?
- Laparoscopic versus open distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
- Pregnant or breast-feeding patients. Fertile female patients who are positive in pregnancy test.
- Drug Administration for Neoadjuvant Chemotherapy
- Inadequate functions of marrow or organs:
- Absolute Neutrophil Count (ANC) < 1.5 x 109/L II. Platelet (PLT) < 100 x 109/L III. Hemoglobin (Hb) ≤ 9 g/dL IV. AST> 2.5 x ULN, ALT> 2.5 x ULN V. ALP > 2.5 x ULN VI. Total Bilirubin (T. Bil) > 1.5 x ULN VII. Serum creatinine (Cr) > 1.5 x ULN
- Patients who have peripheral neuropathy with clinical signs of Grade≥2 (NCI CTCAE v4.03) or with absence of deep tension reflex (DTR).
- Patients with hypersensitivity history of the investigational drug (5-FU, Oxaliplatin, Docetaxel).
- Patients who are on treatment with warfarin or coumarin anticoagulants.
- Patients who are on immunosuppressive therapy.
- Patients who are receiving co-medication with Cytochrome P450 2A6 inducer, inhibitor, and substrate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Joong-Min Park, MD contact
About this study
Official title: A Multicenter Prospective Phase II Comparative Study of Laparoscopic Versus Open Distal Gastrectomy After Neoadjuvant Chemotherapy for the Treatment of Locally Advanced Gastric Cancer Patients
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.
Read the detailed description
The effect of neoadjuvant chemotherapy on locally advanced gastric cancer was confirmed from a prospective clinical trial. Oncologic safety and excellence of the laparoscopic gastrectomy surgery was recently established for locally advanced gastric cancer.
However, neither technical nor oncologic stability was established for laparoscopic gastrectomy surgery after neoadjuvant chemotherapy. Anticipated benefits from laparoscopic gastrectomy surgery after neoadjuvant chemotherapy are as follows: 1) Reduced postoperative complications; 2) Reduced intra- or postoperative transfusion and patient's pain after surgery; 3) Enhance postoperative recovery (shortened hospitalization duration); 4) Facilitate completion rate of adjuvant chemotherapy.
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
- Being tested
- Laparoscopic versus open distal gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic versus open distal gastrectomyProcedure or surgery
Laparoscopic versus open distal gastrectomy after neoadjuvant chemotherapy for locally advanced gastric cancer
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic distal gastrectomy | Experimental | Laparoscopic distal gastrectomy after neoadjuvant chemotherapy for the treatment of locally advanced gastric cancer patients Receives: 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 Receives: Procedure: Laparoscopic versus open distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of harvested lymph nodes in D2 lymph node dissection
number of lymph nodes, pathologically proven after surgery
Measured: 2 weeks after operation when the pathologic report is available
Secondary outcomes (5)
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.
Measured: 3 years after randomization
3 year relapse free survival
RFS is defined as time from the point of randomization to tumor relapse or death
Measured: 3 years after randomization
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.
Measured: 90 days after operation
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.
Measured: 2 weeks after operation when the pathologic report is available
Conversion to open surgery
Defined as a case which the laparoscopic surgery was converted to an open surgery in the operation time, because of reasons including combined organ resection due to adjacent organ invasion, severe intra-abdominal adhesion, or serious intraoperative bleeding.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Kyu Park, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658589
- Sponsor's protocol ID
- H2020-0407
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Phase II Comparative Study of Laparoscopic Versus Open Distal Gastrectomy After Neoadjuvant Chemotherapy for the Treatment of Locally Advanced Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT04658589
- Acronym / sponsor ID
- H2020-0407
- Conditions
- Stomach Neoplasm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The effect of neoadjuvant chemotherapy on locally advanced gastric cancer was confirmed from a prospective clinical trial. Oncologic safety and excellence of the laparoscopic gastrectomy surgery was recently established for locally advanced gastric cancer.
However, neither technical nor oncologic stability was established for laparoscopic gastrectomy surgery after neoadjuvant chemotherapy. Anticipated benefits from laparoscopic gastrectomy surgery after neoadjuvant chemotherapy are as follows: 1) Reduced postoperative complications; 2) Reduced intra- or postoperative transfusion and patient's pain after surgery; 3) Enhance postoperative recovery (shortened hospitalization duration); 4) Facilitate completion rate of adjuvant chemotherapy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic distal gastrectomy | Experimental | Procedure: Laparoscopic versus open distal gastrectomyLaparoscopic distal gastrectomy after neoadjuvant chemotherapy for the treatment of locally advanced gastric cancer patients |
| Open distal gastrectomy | Active comparator | Procedure: Laparoscopic versus open distal gastrectomyOpen distal gastrectomy after neoadjuvant chemotherapy for the treatment of locally advanced gastric cancer patients |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (24 listed)
- Methodologies
- Drug Administration for Neoadjuvant Chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic versus open distal gastrectomyLaparoscopic versus open distal gastrectomy after neoadjuvant chemotherapy for locally advanced gastric cancer | Procedure or surgery | Laparoscopic distal gastrectomy, Open distal gastrectomy |
Primary outcome
Number of harvested lymph nodes in D2 lymph node dissection
Time frame: 2 weeks after operation when the pathologic report is available
number of lymph nodes, pathologically proven after surgery
5 secondary outcomes
3 year progression free survival
Time frame: 3 years after randomization
3 year relapse free survival
Time frame: 3 years after randomization
Comparison of postoperative morbidity and mortality
Time frame: 90 days after operation
Curative resection rate
Time frame: 2 weeks after operation when the pathologic report is available
Conversion to open surgery
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joong-Min Park, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic versus open distal gastrectomy in people with Stomach Neoplasm, run by Chonnam National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young-Kyu Park, MD (+82-10-7173-1196, parkyk@jnu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of harvested lymph nodes in D2 lymph node dissection (time frame: 2 weeks after operation when the pathologic report is available). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.