Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy

NCT ID: NCT03322969

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-23

Study Completion Date

2023-08-31

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.

Conditions

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Locally Advanced Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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receiving modified chemotherapy

Paclitaxel/DDP

Group Type EXPERIMENTAL

Paclitaxel/DDP

Intervention Type DRUG

receiving the modified chemotherapy

receiving the original chemotherapy

XELOX/SOX

Group Type ACTIVE_COMPARATOR

XELOX/SOX

Intervention Type DRUG

receiving the original chemotherapy

Interventions

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Paclitaxel/DDP

receiving the modified chemotherapy

Intervention Type DRUG

XELOX/SOX

receiving the original chemotherapy

Intervention Type DRUG

Other Intervention Names

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Group A Group B

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lin Zhao, Doctor

Role: STUDY_DIRECTOR

Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Locations

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Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiang Wang, Doctor

Role: CONTACT

011-86-10-69151279

Lin Zhao, Doctor

Role: CONTACT

011-86-10-69151279

Facility Contacts

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Xiang Wang, Doctor

Role: primary

011-86-10-69151279

Other Identifiers

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NAC-GC

Identifier Type: -

Identifier Source: org_study_id

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