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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Krankenhaus Nordwest
• Treatments: Docetaxel; Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

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