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

NCT ID: NCT03646591

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-15

Study Completion Date

2018-08-20

Brief Summary

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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

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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.

Conditions

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Chemotherapy Effect

Keywords

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gastric cancer neoadjuvant chemotherapy FLOT regimen

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Chemotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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FLOT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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BIRENDRA KUMAR SAH

Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birendra K Sah, PH D

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Chen Li, PH D

Role: STUDY_DIRECTOR

Ruijin Hospital

Zhenggang Zhu, PH D

Role: STUDY_CHAIR

Ruijin Hospital

Locations

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Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanhgai, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 33537232 (View on PubMed)

Other Identifiers

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Dragon III- Pilot study

Identifier Type: -

Identifier Source: org_study_id