The aim of the trial is to investigate the clinical efficacy and toxicity of perioperative chemotherapy with leucovorin, oxaliplatin, docetaxel and S-1 (LOTS) in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who receive a curative surgery.
The study is an open-label, single-arm, single-country and multi-center phase II investigator-initiated trial. Patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who enroll the trial will receive perioperative chemotherapy with LOTS (14 days as a cycle) 4 cycles every 2 weeks, followed by operation and another 4 cycles every 2 weeks post-operatively. The primary outcome is pathological response or curative resection rate. The secondary outcome includes recurrence-free survival, overall survival, disease control rate, protocol completion rate and adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Perioperative chemotherapy with LOTS
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
RECRUITINGChina Medical University Hospital
Taichung, Taiwan
NOT_YET_RECRUITINGNational Cheng Kung University Hospital
Tainan, Taiwan
RECRUITINGPathological response
the tumor pathological response after pre-operative chemotherapy with LOTS plus curative surgery. The pathological response is defined by tumor evaluation of complete, partial or no response according to tumor regression grading (TRG)
Time frame: after pre-operative chemotherapy and curative surgery (Week 11 to 13)
Curative resection rate
the rate of margin-free (R0) resection in the absence of macro- or microscopic residual tumors remaining at the primary tumor bed
Time frame: after pre-operative chemotherapy and curative surgery (Week 11 to 13)
Recurrence-free survival
the time interval from the initiation of trial treatment to disease recurrence, progression or death at any causes
Time frame: From date of the initiation of trial treatment until the date of disease recurrence, progression or death at any causes, whichever came first, assessed up to 48 months
Overall survival
the time interval from the initiation of trial treatment to death at any causes
Time frame: From date of the initiation of trial treatment until the date of death at any causes, assessed up to 48 months
Disease control rate
the rate of patients remaining in disease control (complete, partial response and stable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines version 1.1) lasting at least three months
Time frame: From date of the initiation of trial treatment until the date of recurrence/death events, withdrawal from the trial at any causes, termination/completion of the trial, whichever came first, assessed up to 48 months
Protocol completion rate
Clinical Trial Center, National Cheng-Kung University Hospital
CONTACT
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Taipei Veterans General Hospital
Taipei, Taiwan
NOT_YET_RECRUITINGthe rate of patients completing the pre-specified protocol treatment
Time frame: From date of the initiation of trial treatment until the date of recurrence/death events, withdrawal from the trial at any causes, termination/completion of the trial, whichever came first, assessed up to 48 months
Treatment-emergent adverse event rate
the rate of protocol treatment-emergent adverse events, as graded by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: From date of the initiation of trial treatment until the date of recurrence/death events, withdrawal from the trial at any causes, termination/completion of the trial, whichever came first, assessed up to 48 months