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Feasibility and Safety of Neoadjuvant Chemotherapy (FLOT ) for Gastric Cancer Patients in China

Sponsor
Ruijin Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03646591
Collaborator
(none)
10
Enrollment
1
Location
9.1
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale randomized controlled trial (RCT) to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. Investigator assessed the FLOT regimen for safety and feasibility in Chinese gastric cancer patients.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale RCT to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. FLOT regimen was prescribed for German patients and various questions are raised by experts from Eastern countries. As the FLOT regimen was officially included in NCCN 2018 guidelines, the investigator used standard protocol of FLOT regimen on Chinese gastric cancer patients. Safety and feasibility were assessed carefully to provide basic data for further large scale studies in China.

Study Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pilot Study on Feasibility and Safety of FLOT Regimen as Neoadjuvant Chemotherapy in Chinese Gastric Cancer Patients
Actual Study Start Date :
Nov 15, 2017
Actual Primary Completion Date :
Aug 20, 2018
Actual Study Completion Date :
Aug 20, 2018

Arms and Interventions

Arm Intervention/Treatment
Neoadjuvant chemotherapy

FLOT Chemotherapy regimen A cycle consist of Day 1: 5-fluorouracil (5-FU) 2600mg/M2 intravenous Via peripherally inserted central catheter (PICC) for 24 hour Day 1: Leucovorin 200mg/M2 intravenous Day 1: Oxaliplatin 85mg/ M2 intravenous Day 1: Docetaxel 50mg/M2 intravenous Repeated every 15th day

Drug: Chemotherapy
Patients will receive four cycles of the standard dose of FLOT chemotherapy prior to curative gastrectomy. And four cycles of the FLOT chemotherapy is recommended after surgery. Preventive antiemetic and dexamethasone are allowed before chemotherapy, growth factor, or other supportive medicines are allowed for treatment only. Surgical intervention is allowed for acute bleeding or other surgical emergencies.
Other Names:
  • FLOT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Completion rate of preoperative FLOT regimen [upto 3 months]

      How many patients completed the plan preoperative chemotherapy regimen

    Secondary Outcome Measures

    1. Adverse events [Upto three months]

      Chemotherapy related adverse events according to the CTCAE version 3.0

    2. Pathological response rate [Upto three months]

      According to tumor regression grading(TRG)

    3. Postoperative morbidity [Upto one month after hospital discharge]

      Postoperative complications

    4. Postoperative mortality [Upto one month after hospital discharge]

      Death due to surgical complication

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Sex: all

    • Histology confirmed adenocarcinoma of the stomach or esophagogastric junction.

    • Clinical stage: Clinical Tumor-Node-Metastasis (cTNM): stage III，IVa

    • Performance status: Eastern Cooperative Oncology Group ECOG 0- 2

    • Adequate renal, hepatic, hematologic, and pulmonary function.

    • Written informed consent

    Exclusion Criteria:

    • Uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities

    • Distant metastases

    • Prior chemo or radiotherapy

    • Inclusion in another clinical trial

    • Known contraindications or hypersensitivity for planned chemotherapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai Shanhgai China 200025

    Sponsors and Collaborators

    • Ruijin Hospital

    Investigators

    • Principal Investigator: Birendra K Sah, PH D, Ruijin Hospital
    • Study Director: Chen Li, PH D, Ruijin Hospital
    • Study Chair: Zhenggang Zhu, PH D, Ruijin Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BIRENDRA KUMAR SAH, Surgeon, Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT03646591
    Other Study ID Numbers:
    • Dragon III- Pilot study
    First Posted:
    Aug 24, 2018
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by BIRENDRA KUMAR SAH, Surgeon, Ruijin Hospital
    gastric cancer
    neoadjuvant chemotherapy
    FLOT regimen
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Nov 13, 2020