Surgery Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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