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

• Status: Unknown status
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, patients with adenocarcinoma of the stomach, gastro-esophageal junction or the distal esophagus who seem operable with curative intent according to oncological and surgical assessment are treated with 3 preoperative cycles of DCX (Docetaxel, Cisplatin, Capecitabine) followed by surgical resection, followed by 3 postoperative cycles of DCX.

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

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborators: Roche Pharma AG; Sanofi
• Treatments: Capecitabine; Cisplatin; Docetaxel

Criteria

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)