Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy

Locally Advanced Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03322969
• Other study ID #: NAC-GC
• Status: Recruiting
• Phase: Phase 2
• Start date: August 23, 2017
• Est. completion date: August 2023

Study information

• Verified date: February 2021
• Source: Peking Union Medical College Hospital
• Contact: Xiang Wang, Doctor
• Phone: 011-86-10-69151279
• Email: wangxiang5123[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Paclitaxel/DDP
receiving the modified chemotherapy
• XELOX/SOX
receiving the original chemotherapy

Locations

Country	Name	City	State
China	Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival	DFS between two arms	3 year