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

PHASE3CompletedINTERVENTIONAL
Enrollment

183

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

August 27, 2024

Study Completion Date

August 27, 2024

Conditions
Gastric Cancer
Interventions
DRUG

5-Fluorouracil

2600 mg/m², d1 i.v., every 2 weeks

DRUG

Leucovorin

200 mg/m², d1, i.v., every 2 weeks

DRUG

Oxaliplatin

85 mg/m², d1, i.v., every 2 weeks

DRUG

Docetaxel

50mg/m², d1, i.v., every 2 weeks

DRUG

Trastuzumab

4 mg/kg BW (6 mg loading dose at 1st administration), i.v. for 1 h, d1, i.v., every two weeks

DRUG

sodium folinate

can be used to replace leucovorin (calcium folinate)

PROCEDURE

Surgery

Aim of surgical resection is a complete (R0) resection of the primary tumor and the metastases or a complete macroscopic cytoreduction of the metastases.

Trial Locations (1)

60488

Krankenhaus Nordwest, Frankfurt am Main

Sponsors
All Listed Sponsors
collaborator

German Research Foundation

OTHER

collaborator

Arbeitsgemeinschaft fur Internistische Onkologie

OTHER

lead

Krankenhaus Nordwest

OTHER