Dragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
NCT ID: NCT04384601
Last Updated: 2021-07-19
Study Results
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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NOT_YET_RECRUITING
PHASE3
246 participants
INTERVENTIONAL
2021-09-30
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOX Chemotherapy
Three preoperative and three postoperative cycles of SOX chemotherapy
A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily)
Repeated every 21st day
Chemotherapy
Perioperative chemotherapy will be administered according to description in two arms.
FLOT Chemotherapy
Four preoperative and four postoperative cycles of FLOT chemotherapy
A cycle consist of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via intravenous peripherally inserted central venous catheter(PICC) for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous
Repeated every 15th day
Chemotherapy
Perioperative chemotherapy will be administered according to description in two arms.
Interventions
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Chemotherapy
Perioperative chemotherapy will be administered according to description in two arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical stage: Clinical Tumor-Node-Metastasis (cTNM:) stage III
* Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic and pulmonary function.
* Written informed consent
Exclusion Criteria
* Distant metastases (including retroperitoneal lymph node)
* Locally advanced inoperable disease (Clinical assessment)
* Relapse of gastric cancer
* Malignant secondary disease
* Prior chemo or radio therapy
* Inclusion in another clinical trial
* Known contraindications or hypersensitivity for planned chemotherapy
18 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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BIRENDRA KUMAR SAH
Surgeon
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, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Dragon III-Phase 3
Identifier Type: -
Identifier Source: org_study_id
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