Overview

Chemotherapy Alone vs. Chemotherapy + Surgical Resection in Patients With Limited-metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Status:
Recruiting

Trial end date:
2021-12-01

Target enrollment:

Participant gender:

Summary

Previously untreated patients with limited metastatic stage (see protocol for details on criteria) will receive 4 cycles of FLOT (5-Fluorouracil, Leucovorin, Oxaliplatin and Docetaxel). Patients without disease progression will be randomized 1:1 to receive additional chemotherapy cycles (4-8 cycles of FLOT) or surgical resection followed by subsequent chemotherapy (4-8 cycles of FLOT). Main objective of the study is overall survival. Most important secondary objective is the quality of life under treatment and during follow-up.

Phase:

Phase 3

Details

Lead Sponsor:

Krankenhaus Nordwest

Collaborators:

Arbeitsgemeinschaft fur Internistische Onkologie
German Research Foundation

Treatments:

Docetaxel
Fluorouracil
Leucovorin
Levoleucovorin
Oxaliplatin
Trastuzumab