Prospective Study With FLOT in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
This trial is active, not recruiting.
|Conditions||gastric cancer, adenocarcinoma of the esophagogastric junction|
|Treatments||docetaxel, 5-fluorouracil, oxaliplatin, folinic acid|
|Start date||February 2009|
|End date||January 2012|
|Trial size||250 participants|
|Trial identifier||NCT00849615, S396 FLOT3|
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.
|Intervention model||single group assignment|
time frame: every 2 weeks during study, every 3 months follow-up
Pharmacogenetic risk profile
time frame: once at beginning
Quality of Life
time frame: every 8 weeks
Progression free survival (PFS) and response rate (Stratum B and C)
time frame: every 8 weeks
rate of R0-resections, rate of pathological remissions and perioperative morbidity and mortality in stratum A and B Perioperative Morbidität und Mortalität in dem Arm A und ggf. B
time frame: after surgical intervention
Male or female participants at least 18 years old.
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 - Pregnancy and lactation
|Official title||A Prospective Multicenter Study With 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction|
|Description||250 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 enrolment a unique and detailed clinical evaluation of the dissemination of the disease will be done which includes a differentiated regard of the M-category in the TNM classification. A prospective stratification will classify the patients as having either (A) locally advanced, (B) limited metastatic, or (C) extensive metastatic disease. In addition, the pharmacogenetic risk profile of the patients will be evaluated by a combined analysis of two genetic polymorphisms of the metabolism of the applied substances (XPD312, GSTT1). For the assessment of the disease, reference regions are examined by CT or MRI scans and if applicable endoscopy prior to the start of the study, every 2 months during and after the end of therapy until progression of the disease occurs. Evaluation of quality of life (by standard forms like EORTC-Q30 and others) is continued after progression. Clinical examinations (blood count, assessment of toxicity, anamnesis) is performed every two weeks for evaluation of toxicity and application of chemotherapy. After informed consent is given, peripheral blood of the patient will be analysed for the pharmacogenetic risk profile. Representative tumor material will be analysed by immunohistochemistry and quantitative PCR for the expression of several molecular factors.|
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