Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy Versus Receiving the Original Chemotherapy in Locally Advanced Gastric Cancer: a Randomized Controlled Study

Conditions
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Locally Advanced Gastric Cancer

Intervention / Treatment
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* Drug: Paclitaxel/DDP
* Drug: XELOX/SOX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: receiving modified chemotherapy<br>Paclitaxel/DDP | Drug: Paclitaxel/DDP<br>* receiving the modified chemotherapy<br>* Other names: Group A;|
| Active Comparator: receiving the original chemotherapy<br>XELOX/SOX | Drug: XELOX/SOX<br>* receiving the original chemotherapy<br>* Other names: Group B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | DFS between two arms | 3 year |