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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00737373
Other study ID # FLOT65+
Secondary ID
Status Completed
Phase Phase 2
First received August 18, 2008
Last updated September 18, 2012
Start date August 2007
Est. completion date March 2011

Study information

Verified date August 2012
Source Krankenhaus Nordwest
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Description:

Patients with locally advanced, potentially operable or metastatic gastric cancer or adenocarcinoma of the esophagogastric junction without prior therapy in the palliative setting are treated with:

- 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)


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date March 2011
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction

- no prior chemotherapy in metastatic state

- adequate blood and biochemistry parameters

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Docetaxel
50mg/m2 qd15
5-Fluorouracil
2600mg/m2 qd15
Oxaliplatin
85mg/m2 qd15
folinic acid
200mg/m2 qd15

Locations

Country Name City State
Germany Krankenhaus Nordwest Frankfurt

Sponsors (1)

Lead Sponsor Collaborator
Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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, Jäger 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. — View Citation

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, Jäger 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary response (WHO criteria) staging every 8 weeks No
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