At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed, medically operable, resectable diffuse or mixed type adenocarcinoma of gastroesophageal junction (AEG II-III) or stomach (uT3, uT4a, any N, M0) or any T N+ M0
- ✓Received 3 to 6 cycles of neoadjuvant FLOT
- ✓No preceding cytotoxic or targeted therapy other than neoadjuvant FLOT
- ✓No prior partial or complete tumor resection
- ✕No neoadjuvant therapy or neoadjuvant therapy other than FLOT
- ✕Known hypersensitivity to 5-FU, leucovorin, oxaliplatin, or docetaxel
- ✕Contraindications to 5-FU, leucovorin, oxaliplatin, or docetaxel
- ✕Clinically significant active coronary heart disease, cardiomyopathy, or congestive heart failure NYHA III-IV
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Preventive HIPEC in Combination With Perioperative FLOT Versus FLOT Alone for Resectable Diffuse Type Gastric and Gastroesophageal Junction Type II/III Adenocarcinoma - The Phase III "PREVENT" Trial of the AIO /CAOGI /ACO
In Brief
A Phase 3 clinical trial evaluating 5-Fluorouracil, Leucovorin, and 3 other interventions for Gastric Cancer and Gastroesophageal Junction Adenocarcinoma. Currently recruiting, targeting 200 participants across 15 sites.
Detailed Summary
This is a multicenter, randomized, controlled, open-label study evaluating efficacy and safety of perioperative FLOT chemotherapy plus intraoperative HIPEC versus FLOT chemotherapy alone in patients with resectable localized and locally advanced diffuse and mixed type adenocarcinoma of the stomach and Type II/III GEJ.
Study Details
Timeline
Interventions
Day 1 q2w: 2600 mg/m² IV over 24 hours
Day 1 q2w: 200 mg/m² IV over 30 minutes
Day 1 q2w: 85 mg/m² IV over 2 hours
Day 1 q2w: 50 mg/m² IV over 1 hour
intraoperative: 75mg/m² intraabdominal solution over 1 hour and 30 minutes