Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2017
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 23, 2017
CompletedFirst Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedFebruary 26, 2021
February 1, 2021
4.9 years
October 24, 2017
February 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
disease free survival
DFS between two arms
3 year
Study Arms (2)
receiving modified chemotherapy
EXPERIMENTALPaclitaxel/DDP
receiving the original chemotherapy
ACTIVE COMPARATORXELOX/SOX
Interventions
receiving the modified chemotherapy
receiving the original chemotherapy
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100032, China
Study Officials
- STUDY DIRECTOR
Lin Zhao, Doctor
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2017
First Posted
October 26, 2017
Study Start
August 23, 2017
Primary Completion
August 1, 2022
Study Completion
August 1, 2023
Last Updated
February 26, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share