Optimizing the Strategy for Preoperative Chemotherapy in Locally Advanced Gastric/Gastroesophageal Cancer

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: S-1; Drug: Oxaliplatin; Drug: Trastuzumab; Drug: Docetaxel

• Registration Number: NCT02725424
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-28
• Study First Posted: 2016-04-01
• Primary Completion: 2018-12
• Study Completion: 2019-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-14
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Her2 Positive with SOX	S-1	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.
Her2 Positive with SOX	Oxaliplatin	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.
Her2 Negative with SOX	S-1	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.
Her2 Positive with SOXT	S-1	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.
Her2 Positive with SOXT	Trastuzumab	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.
Her2 Positive with SOXT	Oxaliplatin	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.
Her2 Negative with DOS	S-1	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.
Her2 Negative with SOX	Oxaliplatin	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.
Her2 Negative with DOS	Oxaliplatin	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.
Her2 Negative with DOS	Docetaxel	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.

Primary Outcome Measures

Name	Time	Method
major Pathological response rate	40 months

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China