Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy

Phase 2

• Conditions: Locally Advanced Gastric Cancer
• Interventions: Drug: XELOX/SOX; Drug: Paclitaxel/DDP

• Registration Number: NCT03322969
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of \<50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy.

Detailed Description

For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of \<50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy. Overall survival and disease-free survival will be observed between two groups.

Study Timeline

• Study Start: 2017-08-23
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-26
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-26
• Primary Completion: 2022-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• TNM stage of T2-T4 or positive regional lymph nodes, according to the American Joint Committee on Cancer (AJCC) 7.0 staging system, verified by enhanced abdominal computed tomography (CT) and/or endoscopic ultrasound (EUS), positron emission tomography (PET)/CT scan), with no evidence of distant metastases;
• ECOG performance status score ≤2 without serious heart, lung, liver, kidney, or hematological dysfunctions;
• age ≥18 years old;
• no previous chemotherapy, radiotherapy, or surgical treatment for gastric cancer;
• gastrectomy was performed after preoperative chemotherapy if imaging studies did not confirm disease progression (according to the Response Evaluation Criteria in Solid Tumors (RECIST)) ;
• signed the informed consent form.

Exclusion Criteria

• All do not reach the inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
receiving the original chemotherapy	XELOX/SOX	XELOX/SOX
receiving modified chemotherapy	Paclitaxel/DDP	Paclitaxel/DDP

Primary Outcome Measures

Name	Time	Method
disease free survival	3 year	DFS between two arms

Trial Locations

Locations (1)

Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China