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Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy

Primary Purpose

Locally Advanced Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paclitaxel/DDP
XELOX/SOX
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

receiving modified chemotherapy

receiving the original chemotherapy

Arm Description

Paclitaxel/DDP

XELOX/SOX

Outcomes

Primary Outcome Measures

disease free survival
DFS between two arms

Secondary Outcome Measures

Full Information

First Posted
October 24, 2017
Last Updated
February 23, 2021
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03322969
Brief Title
Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
receiving modified chemotherapy
Arm Type
Experimental
Arm Description
Paclitaxel/DDP
Arm Title
receiving the original chemotherapy
Arm Type
Active Comparator
Arm Description
XELOX/SOX
Intervention Type
Drug
Intervention Name(s)
Paclitaxel/DDP
Other Intervention Name(s)
Group A
Intervention Description
receiving the modified chemotherapy
Intervention Type
Drug
Intervention Name(s)
XELOX/SOX
Other Intervention Name(s)
Group B
Intervention Description
receiving the original chemotherapy
Primary Outcome Measure Information:
Title
disease free survival
Description
DFS between two arms
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Wang, Doctor
Phone
011-86-10-69151279
Email
wangxiang5123@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Zhao, Doctor
Phone
011-86-10-69151279
Email
wz20010727@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Zhao, Doctor
Organizational Affiliation
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Wang, Doctor
Phone
011-86-10-69151279
Email
wangxiang5123@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy

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