Status:
UNKNOWN
Study to Evaluate Safety and Efficacy of Perioperative Chemotherapy With Docetaxel, Cisplatin and Capecitabine (DCX) in Patients With Gastro-esophageal Cancer
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Roche Pharma AG
Sanofi
Conditions:
Gastric Cancer
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 a...
Detailed Description
Perioperative chemotherapy has been shown to significantly improve the R0 resection rate, the disease free survival and the overall survival in patients with adenocarcinoma of the distal esophagus, th...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00865982
Start Date
September 1 2008
End Date
September 1 2015
Last Update
August 5 2011
Active Locations (9)
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1
HELIOS-Klinik Bad Saarow
Bad Saarow, Germany
2
Klinik für Hämatologie, Onkologie und Tumorimmunologie, Charite Campus Buch
Berlin, Germany
3
Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charite Campus Benjamin-Franklin
Berlin, Germany
4
Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Charite Campus Virchow Klinikum
Berlin, Germany