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Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03322969
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
71.3
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 23, 2017
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: receiving modified chemotherapy

Paclitaxel/DDP

Drug: Paclitaxel/DDP
receiving the modified chemotherapy
Other Names:
  • Group A

    		•
    Active Comparator: receiving the original chemotherapy

    XELOX/SOX

    Drug: XELOX/SOX
    receiving the original chemotherapy
    Other Names:
  • Group B

    		•

    Outcome Measures

    Primary Outcome Measures

    1. disease free survival [3 year]

      DFS between two arms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing Beijing China 100032

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Study Director: Lin Zhao, Doctor, Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT03322969
    Other Study ID Numbers:
    • NAC-GC
    First Posted:
    Oct 26, 2017
    Last Update Posted:
    Feb 26, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Paclitaxel

    Study Results

    No Results Posted as of Feb 26, 2021