FLOT vs. FLOT/Ramucirumab for Perioperative Therapy of Gastric or GEJ Cancer (RAMSES)
NCT02661971 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2022-07-11
Summary
Previous studies provide a strong theoretical rationale for the conduct of a randomized study evaluating the efficacy and safety of ramucirumab in combination with FLOT in the perioperative treatment of resectable adenocarcinoma of the stomach or GEJ.
Conditions
- Stomach Cancer
- Gastroesophageal Junction Cancer
Interventions
- DRUG
-
Docetaxel 50 mg/m², d1
- DRUG
-
Oxaliplatin 85 mg/m², d1
- DRUG
-
Calciumfolinat
Leucovorin 200 mg/m², d1
- DRUG
-
5-FU 2600 mg/m², d1
- BIOLOGICAL
-
Ramucirumab 8mg/kg, d1
Sponsors & Collaborators
-
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
lead OTHER
Principal Investigators
-
Salah-Eddin Al-Batran, Prof. Dr. · Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-30
- Primary Completion
- 2021-12-31
- Completion
- 2022-06-20
Countries
- Germany
- Italy
Study Locations
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