FLOT vs. FLOT/Ramucirumab for Perioperative Therapy of Gastric or GEJ Cancer (RAMSES)

NCT02661971 ↗

Phase 2/3 Completed 180 enrolled Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2016-06
Primary completion: 2021-12
Completion: 2022-06-20

Publications

Goetze TO, Hofheinz RD, Gaiser T, Schmalenberg H, Strumberg D, Goekkurt E, Angermeier S, Zander T, Kopp HG, Pink D, Siegler G, Schenk M, de Vita F, Galizia G, Maiello E, Bechstein WO, Elshafei M, Loose M, Sookthai D, Brulin T, Pauligk C, Homann N, Al-Batran SE. Perioperative FLOT plus ramucirumab for resectable esophagogastric adenocarcinoma: A randomized phase II/III trial of the German AIO and Italian GOIM. Int J Cancer. 2023 Jul 1;153(1):153-163. doi: 10.1002/ijc.34495. Epub 2023 Mar 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramucirumab	Monoclonal antibody	8 mg/kg	Intravenous
Background	Docetaxel	Small molecule	50 mg/m2	Intravenous
Background	Leucovorin	Small molecule	200 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2600 mg/m2	Intravenous

FLOT vs. FLOT/Ramucirumab for Perioperative Therapy of Gastric or GEJ Cancer (RAMSES)

Summary

Timeline

Publications

Drugs

Indications