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

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 : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
BIRENDRA KUMAR SAH, Ruijin Hospital

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
Chemotherapy Effect Drug: Chemotherapy

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.

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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 : November 15, 2017
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Group/Cohort 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 Name: FLOT




Primary Outcome Measures :
  1. Completion rate of preoperative FLOT regimen [ Time Frame: upto 3 months ]
    How many patients completed the plan preoperative chemotherapy regimen


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Upto three months ]
    Chemotherapy related adverse events according to the CTCAE version 3.0

  2. Pathological response rate [ Time Frame: Upto three months ]
    According to tumor regression grading(TRG)

  3. Postoperative morbidity [ Time Frame: Upto one month after hospital discharge ]
    Postoperative complications

  4. Postoperative mortality [ Time Frame: Upto one month after hospital discharge ]
    Death due to surgical complication



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohort of operable gastric cancer patients.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646591


Locations
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China, Shanhgai
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanhgai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
Investigators
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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
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Responsible Party: BIRENDRA KUMAR SAH, Surgeon, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03646591    
Other Study ID Numbers: Dragon III- Pilot study
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BIRENDRA KUMAR SAH, Ruijin Hospital:
gastric cancer
neoadjuvant chemotherapy
FLOT regimen
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases