A Phase 2 interventional study of FLOT regimen chemotherapy and D2 gastric and imaging metastases resection in Adenocarcinoma of the Stomach / Gastroesophageal, sponsored by Henan Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-03-02.
Sponsored by Henan Cancer Hospital · Phase 2, Interventional, and Treatment
Evaluate survival benefit of surgical treatment after FLOT regimen conversion therapy of Her-2 Negative and single site metastasis adenocarcinoma of the stomach / gastroesophageal compared with chemotherapy, use relevant biomarkers to evaluate the efficacy of chemotherapy and seek for patients with Her-2 negative and metastatic adenocarcinoma of the stomach / gastroesophageal surviving benefit from surgical treatment after the FLOT regimen conversion therapy.
The main organ function meet the following criteria within 7 days before treatment:
blood routine examination( No blood transfusion within 14 days)
blood biochemical examination
Exclusion Criteria:
Patients with any severe and / or uncontrollable disease, including:
After received 4 cycles FLOT regimen chemotherapy , D2 gastric resection and imaging metastases resection was performed. Then continue 4 cycles of FLOT regimen chemotherapy (Chemotherapy begins within 4-6 weeks after surgery)
Drug: FLOT regimen chemotherapy · Procedure: D2 gastric and imaging metastases resection
Continue 4 cycles of the FLOT regimen chemotherapy and evaluate the efficacy every 8 weeks.
Drug: FLOT regimen chemotherapy
FLOT regimen chemotherapy
After received 4 cycles FLOT regimen chemotherapy , D2 gastric resection and imaging metastases resection was performed. Then continue 4 cycles of FLOT regimen chemotherapy (Chemotherapy begins within 4-6 weeks after surgery)
Progression-free Survival (PFS)
From date of randomization until the date of first documented progression or date of death from any cause
Time frame: up to 2 year
Overall survival(OS)
the first day of treatment to death or last survival confirm date
Time frame: up to 24 months
Objective Response Rate (ORR)
From date of randomization until the date of death from any cause
Time frame: up to 1 year
R0 resection rate
Tumor tissue was completely resected as a percentage of all surgical patients
Time frame: up to 1 year
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Henan Cancer Hospital