NCT03646591

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

August 23, 2018

Last Update Submit

November 10, 2020

Conditions

Chemotherapy Effect

Keywords

gastric cancerneoadjuvant chemotherapyFLOT regimen

Outcome Measures

Primary Outcomes (1)

  • Completion rate of preoperative FLOT regimen

    How many patients completed the plan preoperative chemotherapy regimen

    upto 3 months

Secondary Outcomes (4)

  • Adverse events

    Upto three months

  • Pathological response rate

    Upto three months

  • Postoperative morbidity

    Upto one month after hospital discharge

  • Postoperative mortality

    Upto one month after hospital discharge

Study Arms (1)

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

Interventions

ChemotherapyDRUG

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.

Also known as: FLOT
Neoadjuvant chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort of operable gastric cancer patients.

You may qualify if:

  • 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

You may not qualify if:

  • Uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities
  • Distant metastases
  • Prior chemo or radiotherapy
  • Known contraindications or hypersensitivity for planned chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanhgai, 200025, China

Location

Related Publications (1)

  • Sah BK, Xu W, Zhang B, Zhang H, Yuan F, Li J, Liu W, Yan C, Li C, Yan M, Zhu Z. Feasibility and Safety of Perioperative Chemotherapy With Fluorouracil Plus Leucovorin, Oxaliplatin, and Docetaxel for Locally Advanced Gastric Cancer Patients in China. Front Oncol. 2021 Jan 18;10:567529. doi: 10.3389/fonc.2020.567529. eCollection 2020.

    PMID: 33537232DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Birendra K Sah, PH D

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

  • Chen Li, PH D

    Ruijin Hospital

    STUDY DIRECTOR

  • Zhenggang Zhu, PH D

    Ruijin Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 24, 2018

Study Start

November 15, 2017

Primary Completion

August 20, 2018

Study Completion

August 20, 2018

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

CN(1)