NCT00737373

Brief Summary

In this trial, FLOT will be evaluated as therapy option for elderly patients (\>65 years) with advanced gastric cancer in comparison to the well established FLO scheme. The hypothesis is that FLOT is more effective than FLO in elderly patients with acceptable side effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 19, 2012

Status Verified

August 1, 2012

Enrollment Period

2.3 years

First QC Date

August 18, 2008

Last Update Submit

September 18, 2012

Conditions

Gastric CancerAdenocarcinoma of the Esophagogastric Junction

Outcome Measures

Primary Outcomes (1)

  • response (WHO criteria)

    staging every 8 weeks

Study Arms (2)

1

EXPERIMENTAL

FLOT

Drug: DocetaxelDrug: 5-FluorouracilDrug: OxaliplatinDrug: folinic acid

2

ACTIVE COMPARATOR

FLO

Drug: 5-FluorouracilDrug: OxaliplatinDrug: folinic acid

Interventions

DocetaxelDRUG

50mg/m2 qd15

1
5-FluorouracilDRUG

2600mg/m2 qd15

12
OxaliplatinDRUG

85mg/m2 qd15

12
folinic acidDRUG

200mg/m2 qd15

12

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction
  • no prior chemotherapy in metastatic state
  • adequate blood and biochemistry parameters

You may not qualify if:

  • hypersensitivity for 5-FU, Leucovorin, Oxaliplatin or Docetaxel
  • KHK, cardiomyopathy or cardiac insufficiency
  • malignancy \<5 years ago
  • brain metastases
  • severe internal disease or inadequate blood and biochemistry parameters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krankenhaus Nordwest

Frankfurt, 60488, Germany

Location

Related Publications (4)

  • Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, Rethwisch V, Seipelt G, Homann N, Wilhelm G, Schuch G, Stoehlmacher J, Derigs HG, Hegewisch-Becker S, Grossmann J, Pauligk C, Atmaca A, Bokemeyer C, Knuth A, Jager E; Arbeitsgemeinschaft Internistische Onkologie. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008 Mar 20;26(9):1435-42. doi: 10.1200/JCO.2007.13.9378.

    PMID: 18349393BACKGROUND

  • Al-Batran SE, Hartmann JT, Hofheinz R, Homann N, Rethwisch V, Probst S, Stoehlmacher J, Clemens MR, Mahlberg R, Fritz M, Seipelt G, Sievert M, Pauligk C, Atmaca A, Jager E. Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie. Ann Oncol. 2008 Nov;19(11):1882-7. doi: 10.1093/annonc/mdn403. Epub 2008 Jul 31.

    PMID: 18669868BACKGROUND

  • Al-Batran SE, Atmaca A, Hegewisch-Becker S, Jaeger D, Hahnfeld S, Rummel MJ, Seipelt G, Rost A, Orth J, Knuth A, Jaeger E. Phase II trial of biweekly infusional fluorouracil, folinic acid, and oxaliplatin in patients with advanced gastric cancer. J Clin Oncol. 2004 Feb 15;22(4):658-63. doi: 10.1200/JCO.2004.07.042.

    PMID: 14966088BACKGROUND

  • Al-Batran SE, Pauligk C, Homann N, Hartmann JT, Moehler M, Probst S, Rethwisch V, Stoehlmacher-Williams J, Prasnikar N, Hollerbach S, Bokemeyer C, Mahlberg R, Hofheinz RD, Luley K, Kullmann F, Jager E. The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: a randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+). Eur J Cancer. 2013 Mar;49(4):835-42. doi: 10.1016/j.ejca.2012.09.025. Epub 2012 Oct 11.

    PMID: 23063354DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

DocetaxelFluorouracilOxaliplatinLeucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination ComplexesFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Salah Al-Batran, MD

    Krankenhaus Nordwest

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 19, 2008

Study Start

August 1, 2007

Primary Completion

December 1, 2009

Study Completion

March 1, 2011

Last Updated

September 19, 2012

Record last verified: 2012-08

Locations

DE(1)