Study to Evaluate Safety and Efficacy of Perioperative Chemotherapy With Docetaxel, Cisplatin and Capecitabine (DCX) in Patients With Gastro-esophageal Cancer (DCXAIOCHARITE)

Inclusion Criteria:

• Signed and dated consent
• Age between minimum 18 and maximum 75 years
• Primary diagnosis of histologically proven adenocarcinoma of the stomach, the gastro-esophageal junction or an adenocarcinoma of the lower third of the esophagus
• Stage II-III, which is in TNM-staging: T3-4, N0-3, M0 or T2, N1-3, M0 or T1, N2, M0. (equivalent to clinical staging uT3-4NXM0, uT1-2N+M0)
• Intended curative resection according to evaluation of an experienced surgeon
• Karnofsky-performance-index > 70%
• Negative pregnancy blood test at screening but not earlier than 72 hours prior to start of chemotherapy for women with child bearing potential
• Adequate haematologic function and liver and renal function: neutrophils > 1,5 x 109/L; thrombocytes > 100 x 109/L; haemoglobin > 10 g/dl, creatinine clearance > 60 ml/min (calculated according to Cockroft and Gault), total bilirubin < 1,0 x UNL; AST and ALT < 1,5 x UNL, AP < 2,5 x UNL
• Complete staging within 3 weeks prior to start of treatment (CT-scan of thorax and abdomen, endosonography, gastroscopy)
• Ability to keep appointments and follow the study protocol
• By CT-scan, endoscopy or endosonography measurable or evaluable disease

Exclusion Criteria:

• Former therapy of gastro-esophageal cancer (operation, chemo- or radiotherapy)
• Diagnosis of another cancer in the last 5 years prior to study entry which has not been cured by operation only (exception in-situ-carcinoma of the cervix or cured non-melanomatose skin cancer)
• Known dihydropyrimidine-dehydrogenase (DPD)-deficiency
• Known contraindication to the planned chemotherapeutics
• Presence of distant metastases

• Anamnestic known serious disease or other concomitant diseases that affect participation in this study, such as:

  • Instable cardiac disease: symptomatic heart failure, symptomatic coronary artery disease, ventricular cardiac arrhythmia not well controlled with medication, myocardial infarction or resuscitation within 6 month before study
  • Active infection necessitating systemic therapy or uncontrolled infection
  • Interstitial lung diseases (for example: pneumonitis or fibrosis of the lung) and indication for interstitial lung disease in chest x-ray or CT-scan respectively
  • Active inflammatory bowel disease or other bowel diseases which provoke chronic diarrhea (defined as > 4 bowel movements per day)
  • Neurological or psychiatric disease including dementia, epilepsy or untreated, symptomatic brain metastases
  • Limited hearing ability
• Presence of upper GI obstruction, leading to inability to swallow ground tablets
• Presence of acute or chronic systemic infection
• Presence of a bowel obstruction within the last 30 days
• Pregnant or lactating women or women with child bearing potential and men without adequate contraception (high effective contraception, defined as Pearl Index < 1) like birth control pill, hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), realized sterilization or sexual abstinence during the study and at least for 3 months after the last infusion
• Any other situation which may lead to an unacceptable high risk for the patient, when he participates in the study
• Parallel treatment in another clinical study or prior participation in this study
• Treatment with any other therapy against the tumor or any parallel radiation
• Parallel treatment with Sorivudine or an chemically related substance like for example Brivudin
• Symptomatic peripheral neuropathy NCI-CTCAE degree > 2
• Intolerance to the study medication or their galencic ingredients or against 5-FU
• Detention in a psychiatric unit or imprisonment (AMG §40 Abs. 1 Nr. 4)