Clinical trial NCT03646591: Feasibility and Safety of Neoadjuvant Chemotherapy (FLOT ) for Gastric Cancer Patients in China
Official title: Pilot Study on Feasibility and Safety of FLOT Regimen as Neoadjuvant Chemotherapy in Chinese Gastric Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy Effect
Keywords: gastric cancer
neoadjuvant chemotherapy
FLOT regimen
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of operable gastric cancer patients.

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.

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.

Eligibility 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

Primary outcomes:
measure: Completion rate of preoperative FLOT regimen
timeFrame: upto 3 months
Secondary outcomes:
measure: Adverse events
timeFrame: Upto three months
measure: Pathological response rate
timeFrame: Upto three months
measure: Postoperative morbidity
timeFrame: Upto one month after hospital discharge
measure: Postoperative mortality
timeFrame: Upto one month after hospital discharge
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanhgai
Study officials:
affiliation: Ruijin Hospital
name: Birendra K Sah, PH D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Chen Li, PH D
role: STUDY_DIRECTOR
affiliation: Ruijin Hospital
name: Zhenggang Zhu, PH D
role: STUDY_CHAIR
References:
citation: 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.