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Completed

NCT Number: NCT00849615

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

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.

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Key information

Conditions

Gastric Cancer Adenocarcinoma of the Esophagogastric Junction Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Krankenhaus Nordwest

Frankfurt, 60488, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

50mg/m2 qd15

5-fluorouracil

Drug

2600mg/m2 qd15

Oxaliplatin

Drug

85mg/m2 qd15

Folinic acid

Drug

200mg/m2 qd15

Primary outcomes

  1. overall survival

    Time frame: every 2 weeks during study, every 3 months follow-up

Secondary outcomes

  1. Pharmacogenetic risk profile

    Time frame: once at beginning

  2. Quality of Life

    Time frame: every 8 weeks

  3. Progression free survival (PFS) and response rate (Stratum B and C)

    Time frame: every 8 weeks

  4. 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

Sponsors and collaborators

Lead sponsor

Krankenhaus Nordwest

Other

Registry information

Official study 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

Acronym: FLOT3

Important dates

Study start
2009
Primary completion
2012
Study completion
2016
First posted
Feb 24, 2009
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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