Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
NCT ID: NCT04677673
Last Updated: 2020-12-21
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
PHASE2/PHASE3
232 participants
INTERVENTIONAL
2021-01-31
2027-01-31
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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NAC PLUS SURGERY
Patients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy.
Chemotherapy
Modified SOX Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 100mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 60mg/M2 oral (twice daily) Repeated every 22nd day
SURGERY FIRST
Patients undergo curative gastrectomy without any prior chemotherapy.
Curative gastrectomy
Radical gastrectomy with D2 lymph node dissection
Interventions
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Chemotherapy
Modified SOX Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 100mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 60mg/M2 oral (twice daily) Repeated every 22nd day
Curative gastrectomy
Radical gastrectomy with D2 lymph node dissection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical stage: 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 radiotherapy
* Inclusion in another clinical trial
* Known contraindications or hypersensitivity for planned chemotherapy
76 Years
ALL
No
Sponsors
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BIRENDRA KUMAR SAH
OTHER
Responsible Party
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BIRENDRA KUMAR SAH
Principal Investigator
Principal Investigators
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Zhenggang Zhu
Role: STUDY_CHAIR
Ruijin Hospital
Central Contacts
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Zhenggang Zhu
Role: CONTACT
Other Identifiers
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Dragon Senile
Identifier Type: -
Identifier Source: org_study_id