A Randomized, Controlled Phase II Study to Compare Preoperative Chemotherapies in Locally Advanced Gastric/Gastroesophageal Cancer
Overview
- Phase
- Phase 2
- Intervention
- S-1
- Conditions
- Gastric Cancer
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- major Pathological response rate
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a randomized, phase II, open-label study. The purpose of this study is to determine the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer according to their HER-2 expression status.
The primary endpoint of this study: major pathology response rate the second endpoints of this study: pathology complete response rate R0 resection rate Progression-free survival ( PFS) Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse event(AE)
Detailed Description
(HER2, human epidermal growth factor receptor-2) positive patients: After 4 cycles of SOX±Trastuzumab neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive 4 cycles of SOX±Trastuzumab adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team. (HER2, human epidermal growth factor receptor-2,HER2) negative patients： After 4 cycles of DOS or SOX regimen as neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive then 4 cycles of DOS or SOX adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.
Investigators
Aiping Zhou
Chief physician
Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Her2 Positive with SOX
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
Intervention: S-1
Her2 Positive with SOX
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
Intervention: Oxaliplatin
Her2 Positive with SOXT
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks.
Intervention: S-1
Her2 Positive with SOXT
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks.
Intervention: Trastuzumab
Her2 Positive with SOXT
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks.
Intervention: Oxaliplatin
Her2 Negative with SOX
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
Intervention: S-1
Her2 Negative with SOX
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) ,100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
Intervention: Oxaliplatin
Her2 Negative with DOS
Docetaxel 60 mg/m2, ivgtt, d1; Oxaliplatin 100 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) , 100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
Intervention: S-1
Her2 Negative with DOS
Docetaxel 60 mg/m2, ivgtt, d1; Oxaliplatin 100 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) , 100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
Intervention: Oxaliplatin
Her2 Negative with DOS
Docetaxel 60 mg/m2, ivgtt, d1; Oxaliplatin 100 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA \<1.25m2) , 100mg/day (BSA ≥1.25m2, \<1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
Intervention: Docetaxel
Outcomes
Primary Outcomes
major Pathological response rate
Time Frame: 40 months