Oxaliplatin and 5-Fluorouracil With or Without Docetaxel in Elderly Patients (>65 y) With Stomach and Esophagus Cancer
NCT ID: NCT00737373
Last Updated: 2012-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2007-08-31
2011-03-31
Brief Summary
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Detailed Description
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* Arm A: FLO
* Arm B: FLOT
max. 12 cycles
Evaluation of quality of life by standard forms at baseline and then every 2 months until progress of disease. Pharmacogenetic analyses will be done to evaluate a risk profile for platin-based therapies. 140 patients will be treated (70 per arm)
primary endpoint:
* Response Rate
secondary endpoints:
* Prospective Validation of a pharmacogenetic risk profile for patients with advanced GC under first-line therapy with platin/docetaxel
* Evaluation of quality of life
* safety and tolerability
* progression free survival (PFS), time to treatment failure (TTF), overall survival (OS)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
FLOT
Docetaxel
50mg/m2 qd15
5-Fluorouracil
2600mg/m2 qd15
Oxaliplatin
85mg/m2 qd15
folinic acid
200mg/m2 qd15
2
FLO
5-Fluorouracil
2600mg/m2 qd15
Oxaliplatin
85mg/m2 qd15
folinic acid
200mg/m2 qd15
Interventions
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Docetaxel
50mg/m2 qd15
5-Fluorouracil
2600mg/m2 qd15
Oxaliplatin
85mg/m2 qd15
folinic acid
200mg/m2 qd15
Eligibility Criteria
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Inclusion Criteria
* no prior chemotherapy in metastatic state
* adequate blood and biochemistry parameters
Exclusion Criteria
* KHK, cardiomyopathy or cardiac insufficiency
* malignancy \<5 years ago
* brain metastases
* severe internal disease or inadequate blood and biochemistry parameters
65 Years
ALL
No
Sponsors
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Krankenhaus Nordwest
OTHER
Responsible Party
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Principal Investigators
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Salah Al-Batran, MD
Role: STUDY_CHAIR
Krankenhaus Nordwest
Locations
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Krankenhaus Nordwest
Frankfurt, , Germany
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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FLOT65+
Identifier Type: -
Identifier Source: org_study_id