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Feasibility and Safety of FLOT Regimen in Chinese Gastric Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03646591
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
BIRENDRA KUMAR SAH, Ruijin Hospital

Tracking Information
First Submitted Date August 23, 2018
First Posted Date August 24, 2018
Last Update Posted Date August 24, 2018
Actual Study Start Date November 15, 2017
Actual Primary Completion Date August 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2018)
Completion rate of preoperative FLOT regimen [ Time Frame: upto 3 months ]
How many patients completed the plan preoperative chemotherapy regimen
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 23, 2018)
  • Adverse events [ Time Frame: Upto three months ]
    Chemotherapy related adverse events according to the CTCAE version 3.0
  • Pathological response rate [ Time Frame: Upto three months ]
    According to tumor regression grading(TRG)
  • Postoperative morbidity [ Time Frame: Upto one month after hospital discharge ]
    Postoperative complications
  • Postoperative mortality [ Time Frame: Upto one month after hospital discharge ]
    Death due to surgical complication
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Feasibility and Safety of FLOT Regimen in Chinese Gastric Cancer Patients
Official Title Pilot Study on Feasibility and Safety of FLOT Regimen in Chinese Gastric Cancer Patients
Brief Summary 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. Investigator assessed FLOT regimen for safety and feasibility in Chinese gastric cancer patients.
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, investigator used standard protocol of FLOT regimen on Chinese gastric cancer patients. Safety and feasibility was assessed carefully to provide basic data for further large scale studies in China.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cohort of operable gastric cancer patients.
Condition Chemotherapy Effect
Intervention Drug: Chemotherapy
5-FU+CF+Docetaxel+Oxaliplatin
Study Groups/Cohorts Neoadjuvant chemotherapy
A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered A cycle consist of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous Repeated every 15th day
Intervention: Drug: Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 23, 2018)
10
Original Actual Enrollment Same as current
Actual Study Completion Date August 20, 2018
Actual Primary Completion Date August 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Pathology confirmed gastric cancer with cTNM stage III
  • Clinically fit for gastric cancer surgery

Exclusion Criteria:

  • Clinically unfit for gastric cancer surgery
  • Distant metastases
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03646591
Other Study ID Numbers Ruijin GCS-Neoadjuvant
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party BIRENDRA KUMAR SAH, Ruijin Hospital
Study Sponsor BIRENDRA KUMAR SAH
Collaborators Not Provided
Investigators
Principal Investigator: BIRENDRA K SAH, Ph D Ruijin Hospital
PRS Account Ruijin Hospital
Verification Date August 2018