Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Locally Advanced Gastric Cancer

Treatments: Drug: Paclitaxel/DDP; Drug: XELOX/SOX

Study type: Interventional

Funder types: Other

Identifiers

NCT03322969

NAC-GC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

receiving modified chemotherapy

Experimental group

Description:

Paclitaxel/DDP

Treatment:

Drug: Paclitaxel/DDP

receiving the original chemotherapy

Active Comparator group

Description:

XELOX/SOX

Treatment:

Drug: XELOX/SOX