Perioperative FLOT Versus Adjuvant XELOX for Locally Advanced Gastric Cancer - a Randomized Controlled Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a single centre randomised controlled trial, comparing perioperative FLOT versus adjuvant XELOX for locally advanced gastric and esophagogastric junction cancers. Patients with operable clinical T3 or above and N1 or above gastric and esophagastric junction cancer would be recruited. Participants would be randomised to perioperative FLOT versus adjuvant XELOX with curative radical gastrectomy. Primary outcome would be 3 year Disease Free Survival. It was calculated that 110 patients would be required to demonstrate the study hypothesis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Locally advanced adenocarcinoma of stomach or esophagogastric junction (Siewert type II and III), defined by clinical stage ≥T3 and/or ≥N1, in the absence of distant metastasis
• Surgically resectable disease based on clinical staging
• No previous gastrectomy or chemotherapy
• Age 18 or above but less than 80, and
• ECOG ≤2
• Hemoglobin \>/= 8.0 g/dL
• Neutrophils \>/= 1.500/µl
• Platelets ≥ 100.000/µl
• Creatinine clearance ≥ 50 ml/min
⁃ Serum albumin \>25 g/L
Locations
Other Locations
Hong Kong Special Administrative Region
The Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Hon Chi Yip, FRCSEd
hcyip@surgery.cuhk.edu.hk
35052627
Time Frame
Start Date:2022-03-21
Estimated Completion Date:2027-12-31
Participants
Target number of participants:110
Treatments
Experimental: FLOT
Patients randomized to the FLOT arm would receive perioperative FLOT~Regimen:~* Docetaxel 50mg/m2, d1~* 5-FU 2600 mg/m², d1~* Leucovorin 200 mg/m², d1~* Oxaliplatin 85 mg/m², d1~* Every two weeks 4 cycles pre-op and 4 cycles post-op~Granulocyte colony stimulating factor (GCSF) at 30 mu s.c. daily from Day 4 to Day 7 is recommended.~Two weeks after completion of the 4 cycles of pre-op chemotherapy, reassessment endoscopy and CT scan would be performed. Surgery would be performed 4 weeks after pre-op chemotherapy if no distant metastasis was found on CT scan.~Post-op adjuvant FLOT (x 4 cycles) will be started within 10 weeks after surgery.
Active_comparator: XELOX
Patients randomized to adjuvant XELOX arm would receive chemotherapy after surgery.~* Capecitabine - 1,000 mg/m² twice daily.~* Oxaliplatin - IV infusion, 130mg/m²