Gastric CancerPhase 2/3NCT02423278
The Long-term Effect of D4 Lymphadenectomy for Gastric Cancer
A Phase 2/3 study testing Radical Gastrectomy Plus D2 Lymphadenectomy, Radical Gastrectomy Plus D4 Lymphadenectomy and S-1+Oxaliplatin in people with Gastric Cancer and Surgery, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The main purpose of this study is to evaluate the effect of extensive lymphadenectomy procedure in treatment of gastric cancer. This study is designed as a open-label, multi-centers, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastric Cancer, Surgery, Effects of Chemotherapy
- What is being tested?
- Radical Gastrectomy Plus D2 Lymphadenectomy, Radical Gastrectomy Plus D4 Lymphadenectomy and S-1+Oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The informed consent has been obtained from the patient.
- With confirmed pathological diagnosis of gastric cancer and visible para-aortic lymph nodes metastasis.
- Endurable D2/D4 gastrectomy and neoadjuvant chemotherapy.
- With moderate/good ECOG health rating (PS): 0-1 score.
Who cannot join
- Pregnant woman or lactating woman.
- With confirmed distant metastasis in liver, lung, bones, or other organs.
- Intolerable operation or neoadjuvant chemotherapy.
- With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
- With bad compliance or contraindication to enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yulong He, MD, +86 13602839886, yulongh.sysu@gmail.com
About this study
Official title: The Long-term Effect of D4 Lymphadenectomy for Gastric Cancer: a Multicenter, Open-label, Randomized Trial
The main purpose of this study is to evaluate the effect of extensive lymphadenectomy procedure in treatment of gastric cancer. This study is designed as a open-label, multi-centers, randomized controlled trial. The overall survival and free disease survival are primary outcomes, with postoperative complication, hospital charges, and life quality as secondary outcomes.
Read the detailed description
Background: Gastric cancer is the second leading cause of cancer-associated death worldwide, with high incidence in China. The prognosis of advanced gastric cancer is quite poor. Although perioperative chemotherapy may help to prolong survival in cases of advanced disease, radical tumor resection remains the most effective treatment for curable gastric cancer. Nowadays, radical gastrectomy with extended (D2) lymphadenectomy has become the standard for treatment of advanced gastric cancer. However, this surgical procedure cannot achieve a radical tumor resection for most cases with advanced disease. Hence, a more extensive (D2 plus para-aortic nodal dissection, D4) lymphadenectomy along with gastrectomy has been performed in Japan and other Asian countries. A recent study by Sasako et al. indicated that a prophylactic D4 lymphadenectomy did not improve the prognosis of curable gastric cancer, but increased the blood loss and operation time compared with single D2 procedure. We reviewed our database, which had collected almost 2,000 gastric cancer cases since its establishment in 1994, and found that the D4 surgical procedure actually improved the prognosis of T4 tumor and tumor with lymph node metastasis at the second stations. To further confirm the results from our retrospective analysis, we performed a prospective study with multicenter, open-label, and randomized design in the affiliated hospitals of Sun Yat-sen University. This study would be helpful to improve the prognosis of patients with advanced gastric cancer, and find more efficient management for curable gastric cancer.
Method: This study, which started from January, 2011 and planned to close after ten years, has been approved by the ethic committee of Sun Yat-sen University, with written inform consent obtained from all enrolled subjects. Patients who had histologically proven gastric adenocarcinoma and confirmed lymph node metastasis to para-aortic nodes (<3 enlarged lymph nodes) were prospectively enrolled in this trial. A standard D2 lymphadenectomy or D4 procedure was randomly decided by a formal randomization program. The primary end point of this study was overall survival, defined as the time from randomization to death. The secondary end points were recurrence-free survival, postoperative complications, length of stay, and hospital charges. Recurrence-free survival was defined as the time from randomization to the first recurrence of cancer or death from any cause. The follow-up period would last for at least five years after the definitive operation.
Significance: This study would further confirm the efficacy of D2 plus para-aortic nodal dissection(PAND) procedure for management of advanced gastric cancer as compared with the classic D2 lymphadenectomy operation. Moreover, the therapeutic measures employed in current study may guide the future treatment of advanced gastric cancer in China.
- Conditions
- Gastric Cancer, Surgery, Effects of Chemotherapy
- Being tested
- Radical Gastrectomy Plus D2 Lymphadenectomy, Radical Gastrectomy Plus D4 Lymphadenectomy, S-1+Oxaliplatin
- Keywords
- gastrectomy, lymphadenectomy, gastric cancer, adjuvant chemotherapy, overall survival
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical Gastrectomy Plus D2 LymphadenectomyProcedure or surgery
Also called D2 Lymphadenectomy
This surgical procedure is performed by the same high-experienced surgical team as the control arm.
All lymph nodes around stomach (station 1\&2 LNs) must be removed to achieve a radical lymphadenectomy. Para-aortic lymph nodes should not be dissected even if a suspected lymph node metastasis is diagnosed from radiographic exams.
Radical Gastrectomy Plus D4 LymphadenectomyProcedure or surgery
Also called D4 Lymphadenectomy
This surgical procedure is also performed by the same high-experienced surgical team as the control arm.
Lymph nodes around stomach (station 1\&2 LNs) and para-aortic lymph nodes must be removed during the operation.
S-1+OxaliplatinDrug
Also called SOX chemo Regimen
A perioperative chemotherapy, known as SOX regimen, should be performed in each enrolled patient with three-cycle treatments followed after a pathological carcinoma diagnosis. After a radical operation (arm groups), additional five-cycle treatments of adjuvant chemotherapy (SOX regimen) would be performed, followed by follow-up program. The treatment bundles are listed as follows:
- S-1: 40~60mg bid，po, Day1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid）
- Oxaliplatin: 130mg/m2，iv drip for 2h，Day1
| Study group | Role | What they receive |
|---|---|---|
| D4 Lymphadenectomy | Experimental | This is the interventional group in which additional para-aortic lymph nodes are dissected meanwhile.
Under this arm, main therapeutic measures are listed as follows:
* three-cycle SOX chemo regimen (S-1+Oxaliplatin) as neoadjuvant chemotherapy
* radical gastrectomy plus D4 lymphadenectomy
* five-cycle SOX chemo as adjuvant chemotherapy
* five-year follow-up program to evaluate the prognosis. Receives: Procedure: Radical Gastrectomy Plus D4 Lymphadenectomy; Drug: S-1+Oxaliplatin |
| D2 Lymphadenectomy | Experimental | This is the control group in which a classic surgical procedure for gastric cancer is performed.
Under this arm, main therapeutic measures are included as follows:
* three-cycle SOX chemo regimen (S-1+Oxaliplatin) as neoadjuvant chemotherapy
* radical gastrectomy plus D2 lymphadenectomy (Without para-aortic lymph nodes dissection)
* five-cycle SOX chemo as adjuvant chemotherapy
* five-year follow-up program to evaluate the prognosis. Receives: Procedure: Radical Gastrectomy Plus D2 Lymphadenectomy; Drug: S-1+Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: five years after surgery
Relapse-free Survival
Measured: five years after surgery
Secondary outcomes (4)
Early complications
Rate of early postoperative events, such as anastomotic leak, intra-abdominal hemorrhage, adhesive intestinal obstruction and surgical site infection, in each arm.
Measured: within the first 30 days after surgery
Perioperative mortality
Measured: within the first 30 days after surgery
Life quality measured by HRQOL score
a questionnaire form would be sent to each enrolled patients after surgery.
Measured: five years after surgery
Length of Hospital stay
The duration between admission and final discharge from hospital. An average of 4 weeks is expected.
Measured: an expected average of 4 weeks after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startJan 2010
- Primary completionJun 2016 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Sixth Affiliated Hospital, Sun Yat-sen University
- Responsible party
- Principal investigator, Yulong He, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yulong He, MD, Study director, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423278
- Sponsor's protocol ID
- 2010006
- Status last verified
- Apr 2015
- First submitted
- 13 Apr 2015
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effect of D4 Lymphadenectomy for Gastric Cancer: a Multicenter, Open-label, Randomized Trial
- ClinicalTrials.gov ID
- NCT02423278
- Acronym / sponsor ID
- 2010006
- Conditions
- Gastric Cancer, Surgery, Effects of Chemotherapy
- Keywords
- gastrectomy, lymphadenectomy, gastric cancer, adjuvant chemotherapy, overall survival
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Sixth Affiliated Hospital, Sun Yat-sen University
- Study start
- Jan 2010
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Apr 2015 (estimated)
- 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 main purpose of this study is to evaluate the effect of extensive lymphadenectomy procedure in treatment of gastric cancer. This study is designed as a open-label, multi-centers, randomized controlled trial. The overall survival and free disease survival are primary outcomes, with postoperative complication, hospital charges, and life quality as secondary outcomes.
Detailed description
Background: Gastric cancer is the second leading cause of cancer-associated death worldwide, with high incidence in China. The prognosis of advanced gastric cancer is quite poor. Although perioperative chemotherapy may help to prolong survival in cases of advanced disease, radical tumor resection remains the most effective treatment for curable gastric cancer. Nowadays, radical gastrectomy with extended (D2) lymphadenectomy has become the standard for treatment of advanced gastric cancer. However, this surgical procedure cannot achieve a radical tumor resection for most cases with advanced disease. Hence, a more extensive (D2 plus para-aortic nodal dissection, D4) lymphadenectomy along with gastrectomy has been performed in Japan and other Asian countries. A recent study by Sasako et al. indicated that a prophylactic D4 lymphadenectomy did not improve the prognosis of curable gastric cancer, but increased the blood loss and operation time compared with single D2 procedure. We reviewed our database, which had collected almost 2,000 gastric cancer cases since its establishment in 1994, and found that the D4 surgical procedure actually improved the prognosis of T4 tumor and tumor with lymph node metastasis at the second stations. To further confirm the results from our retrospective analysis, we performed a prospective study with multicenter, open-label, and randomized design in the affiliated hospitals of Sun Yat-sen University. This study would be helpful to improve the prognosis of patients with advanced gastric cancer, and find more efficient management for curable gastric cancer.
Method: This study, which started from January, 2011 and planned to close after ten years, has been approved by the ethic committee of Sun Yat-sen University, with written inform consent obtained from all enrolled subjects. Patients who had histologically proven gastric adenocarcinoma and confirmed lymph node metastasis to para-aortic nodes (<3 enlarged lymph nodes) were prospectively enrolled in this trial. A standard D2 lymphadenectomy or D4 procedure was randomly decided by a formal randomization program. The primary end point of this study was overall survival, defined as the time from randomization to death. The secondary end points were recurrence-free survival, postoperative complications, length of stay, and hospital charges. Recurrence-free survival was defined as the time from randomization to the first recurrence of cancer or death from any cause. The follow-up period would last for at least five years after the definitive operation.
Significance: This study would further confirm the efficacy of D2 plus para-aortic nodal dissection(PAND) procedure for management of advanced gastric cancer as compared with the classic D2 lymphadenectomy operation. Moreover, the therapeutic measures employed in current study may guide the future treatment of advanced gastric cancer in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D4 Lymphadenectomy | Experimental | Procedure: Radical Gastrectomy Plus D4 Lymphadenectomy, Drug: S-1+OxaliplatinThis is the interventional group in which additional para-aortic lymph nodes are dissected meanwhile. Under this arm, main therapeutic measures are listed as follows: * three-cycle SOX chemo regimen (S-1+Oxaliplatin) as neoadjuvant chemotherapy * radical gastrectomy plus D4 lymphadenectomy * five-cycle SOX chemo as adjuvant chemotherapy * five-year follow-up program to evaluate the prognosis. |
| D2 Lymphadenectomy | Experimental | Procedure: Radical Gastrectomy Plus D2 Lymphadenectomy, Drug: S-1+OxaliplatinThis is the control group in which a classic surgical procedure for gastric cancer is performed. Under this arm, main therapeutic measures are included as follows: * three-cycle SOX chemo regimen (S-1+Oxaliplatin) as neoadjuvant chemotherapy * radical gastrectomy plus D2 lymphadenectomy (Without para-aortic lymph nodes dissection) * five-cycle SOX chemo as adjuvant chemotherapy * five-year follow-up program to evaluate the prognosis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The informed consent has been obtained from the patient.
- With confirmed pathological diagnosis of gastric cancer and visible para-aortic lymph nodes metastasis.
- Endurable D2/D4 gastrectomy and neoadjuvant chemotherapy.
- With moderate/good ECOG health rating (PS): 0-1 score.
Key exclusion criteria (5 listed)
- Pregnant woman or lactating woman.
- With confirmed distant metastasis in liver, lung, bones, or other organs.
- Intolerable operation or neoadjuvant chemotherapy.
- With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
- With bad compliance or contraindication to enrollment.
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 |
|---|---|---|
| Radical Gastrectomy Plus D2 LymphadenectomyAlso: D2 LymphadenectomyThis surgical procedure is performed by the same high-experienced surgical team as the control arm. All lymph nodes around stomach (station 1\&2 LNs) must be removed to achieve a radical lymphadenectomy. Para-aortic lymph nodes should not be dissected even if a suspected lymph node metastasis is diagnosed from radiographic exams. | Procedure or surgery | D2 Lymphadenectomy |
| Radical Gastrectomy Plus D4 LymphadenectomyAlso: D4 LymphadenectomyThis surgical procedure is also performed by the same high-experienced surgical team as the control arm. Lymph nodes around stomach (station 1\&2 LNs) and para-aortic lymph nodes must be removed during the operation. | Procedure or surgery | D4 Lymphadenectomy |
| S-1+OxaliplatinAlso: SOX chemo RegimenA perioperative chemotherapy, known as SOX regimen, should be performed in each enrolled patient with three-cycle treatments followed after a pathological carcinoma diagnosis. After a radical operation (arm groups), additional five-cycle treatments of adjuvant chemotherapy (SOX regimen) would be performed, followed by follow-up program. The treatment bundles are listed as follows: * S-1: 40~60mg bid，po, Day1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid） * Oxaliplatin: 130mg/m2，iv drip for 2h，Day1 | Drug | D2 Lymphadenectomy, D4 Lymphadenectomy |
Primary outcome
Overall Survival
Time frame: five years after surgery
Relapse-free Survival
Time frame: five years after surgery
4 secondary outcomes
Early complications
Time frame: within the first 30 days after surgery
Perioperative mortality
Time frame: within the first 30 days after surgery
Life quality measured by HRQOL score
Time frame: five years after surgery
Length of Hospital stay
Time frame: an expected average of 4 weeks after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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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. This study is not recruiting at the moment.
Yulong He, MD study director
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Radical Gastrectomy Plus D2 Lymphadenectomy, Radical Gastrectomy Plus D4 Lymphadenectomy and S-1+Oxaliplatin in people with Gastric Cancer and Surgery, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yujie Yuan, MD (+8615018492852, condor.yyj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: five years after surgery). The study lists 2 primary outcomes in all. 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 22 Apr 2015.