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Prospective Study With FLOT in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

NCT00849615 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2016-04-06

No results posted yet for this study

Summary

Patients with locally advanced or metastatic gastric carcinoma or carcinoma of the esophagogastric junction without prior palliative therapy will be treated with 8 cycles of the FLOT scheme (up to 12 cycles if the response is favourable). Prior to enrollment a unique and detailed clinical evaluation of the dissemination of the disease will be done which includes a differentiated regard of the metastatic status. patients will be classified as having either (A) locally advanced, (B) limited metastatic, or (C) extensive metastatic disease. In arms A and B surgical intervention is planned if operability is reached. The hypothesis is that by classifying patients more individually by the state of their disease, patients in arm B will have a significantly prolonged overall survival compared to patients in arm C.

Conditions

Interventions

DRUG

Docetaxel

50mg/m2 qd15

DRUG

5-Fluorouracil

2600mg/m2 qd15

DRUG

Oxaliplatin

85mg/m2 qd15

DRUG

folinic acid

200mg/m2 qd15

Sponsors & Collaborators

  • Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah Al-Batan, MD · Institute of Clinical Cancer Research IKF, UCT - University Cancer Center, Frankfurt, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-01-31
Completion
2016-01-31

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 NCT00849615 on ClinicalTrials.gov