Explorative Phase II Study of Perioperative Treatment in Patients With Adenocarcinoma of the Gastroesophageal Junction or Stomach

NCT01472029 ↗

Phase 2 Completed 53 enrolled AIO-Studien-gGmbH Roche Pharma AG · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the rate of complete pathological responses (percentage of patients with pCR referring to the total number of enrolled and eligible patients), as evaluated centrally by a reference pathologist.

Timeline

Start: 2011-12
Primary completion: 2014-08-25
Completion: 2016-09-12

Outcome

Met primary endpoint

paper The primary endpoint of achieving a pCR >20% was reached. PMID 34019698 ↗

Publications

Hofheinz RD, Hegewisch-Becker S, Kunzmann V, Thuss-Patience P, Fuchs M, Homann N, Graeven U, Schulte N, Merx K, Pohl M, Held S, Keller R, Tannapfel A, Al-Batran SE. Trastuzumab in combination with 5-fluorouracil, leucovorin, oxaliplatin and docetaxel as perioperative treatment for patients with human epidermal growth factor receptor 2-positive locally advanced esophagogastric adenocarcinoma: A phase II trial of the Arbeitsgemeinschaft Internistische Onkologie Gastric Cancer Study Group. Int J Cancer. 2021 Sep 15;149(6):1322-1331. doi: 10.1002/ijc.33696. Epub 2021 May 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	50 mg/m2	Intravenous
Subject	Leucovorin	Small molecule	200 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	Trastuzumab	Monoclonal antibody	4 mg/kg	Intravenous
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	fluorouracil	Small molecule	2600 mg/m2	Intravenous