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Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

Primary Purpose

Esophagogastric Junction Disorder, Neoplasms

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
chemoradiation with weekly 5Fu and oxaliplatin
Perioperative mFLOT
Perioperative FOLFOX
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagogastric Junction Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • informed consensus of the enrolled patients
  • from 18 to 75 years old
  • proven to be primary adenocarcinoma of EGJ
  • pre-operative staging cT3-4N+M0
  • no prior other chemotherapy and/or radiation against the disease
  • normal function of all other vital organs including heart,liver ,kidney and so on
  • Eastern Cooperative Oncology Group performance status: 0~2

Exclusion Criteria:

  • history of other malignancy
  • allergic reaction to capecitabine or oxaliplatin
  • enrolled in other clinical trials
  • abnormal GI tract function
  • dysfunction of other organs
  • pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy
  • other situations judged as not adaptive to the study by investigators

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Chemoradiation

    FLOT

    FOLFOX

    Arm Description

    weekly 5-Fu and oxaliplatin

    Eight perioperative chemotherapy cycles

    Twelve perioperative chemotherapy cycles

    Outcomes

    Primary Outcome Measures

    3 year of disease free survival

    Secondary Outcome Measures

    5 year of overall survival
    Rate of pathological complete remission
    Anastomosis leak rate

    Full Information

    First Posted
    May 22, 2019
    Last Updated
    December 19, 2019
    Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03961841
    Brief Title
    Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma
    Official Title
    A Randomised Controlled Trial Comparing Perioperative FLOT, FOLFOX and Preoperative Chemoradiation for Locally Advanced Esophagogastric Junction Adenocarcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2020 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophagogastric Junction Disorder, Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    900 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chemoradiation
    Arm Type
    Active Comparator
    Arm Description
    weekly 5-Fu and oxaliplatin
    Arm Title
    FLOT
    Arm Type
    Experimental
    Arm Description
    Eight perioperative chemotherapy cycles
    Arm Title
    FOLFOX
    Arm Type
    Experimental
    Arm Description
    Twelve perioperative chemotherapy cycles
    Intervention Type
    Radiation
    Intervention Name(s)
    chemoradiation with weekly 5Fu and oxaliplatin
    Intervention Description
    5Fu 225 mg/m2 IV daily continuous infusion；oxaliplatin 40 mg/m2/week
    Intervention Type
    Drug
    Intervention Name(s)
    Perioperative mFLOT
    Intervention Description
    Perioperative docetaxel 50mg/m2；oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles
    Intervention Type
    Drug
    Intervention Name(s)
    Perioperative FOLFOX
    Intervention Description
    Perioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles
    Primary Outcome Measure Information:
    Title
    3 year of disease free survival
    Time Frame
    3 year
    Secondary Outcome Measure Information:
    Title
    5 year of overall survival
    Time Frame
    5 year
    Title
    Rate of pathological complete remission
    Time Frame
    1 year
    Title
    Anastomosis leak rate
    Time Frame
    1 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: informed consensus of the enrolled patients from 18 to 75 years old proven to be primary adenocarcinoma of EGJ pre-operative staging cT3-4N+M0 no prior other chemotherapy and/or radiation against the disease normal function of all other vital organs including heart,liver ,kidney and so on Eastern Cooperative Oncology Group performance status: 0~2 Exclusion Criteria: history of other malignancy allergic reaction to capecitabine or oxaliplatin enrolled in other clinical trials abnormal GI tract function dysfunction of other organs pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy other situations judged as not adaptive to the study by investigators
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shanshan Li, MD
    Phone
    86-20-38285497
    Email
    lishsh89@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaohui Zhai, MD
    Phone
    86-20-38285497
    Email
    zhaixh@zju.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

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