drugset / Trial / NCT04375605
Neoadjuvant RCT Versus CT for Patients With Locally Advanced, Potentially Resectable Adenocarcinoma of the GEJ
Phase 3
Completed
342 enrolled
University Medical Center Mannheim
Deutsche Krebshilfe e.V., Bonn (Germany) · collabInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, prospective, randomized, stratified, controlled, open-label study comparing neoadjuvant radiochemotherapy with FLOT versus FLOT chemotherapy alone für patients with locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ)
Timeline
- Start
- 2020-06-03
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
Publications
- Klute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044.
- Lorenzen S, Biederstadt A, Ronellenfitsch U, Reissfelder C, Monig S, Wenz F, Pauligk C, Walker M, Al-Batran SE, Haller B, Hofheinz RD. RACE-trial: neoadjuvant radiochemotherapy versus chemotherapy for patients with locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction - a randomized phase III joint study of the AIO, ARO and DGAV. BMC Cancer. 2020 Sep 15;20(1):886. doi: 10.1186/s12885-020-07388-x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcium folinate | Unknown | 200 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 45 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 225 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2600 mg/m2 | Intravenous |