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

NCT02578368 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2024-11-12

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Arbeitsgemeinschaft fur Internistische Onkologie

    collaborator OTHER

  • Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah-Eddin Al-Batran, MD · Institute of Clinical Cancer Research (IKF), Krankenhaus Nordwest; University Cancer Center Frankfurt (UCT)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2024-08-27
Completion
2024-08-27

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02578368 on ClinicalTrials.gov