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NCT Number: NCT03646591

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

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.

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Key information

Conditions

Chemotherapy Effect Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanhgai, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

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

Primary outcomes

  1. Completion rate of preoperative FLOT regimen

    Time frame: upto 3 months

    How many patients completed the plan preoperative chemotherapy regimen

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Pilot Study on Feasibility and Safety of FLOT Regimen as Neoadjuvant Chemotherapy in Chinese Gastric Cancer Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2018
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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