Multicentre, open phase II trial to evaluate safety and efficacy of a perioperative chemotherapy with docetaxel, cisplatin and capecitabin in patients suffering from adenocarcinoma of the stomach, gastroesophageal junction or distal esophagus.

Charité - Universitätsmedizin Berlin0 sites50 target enrollmentJuly 29, 2008

Overview

No summary available.

Registry

who.int

Start Date

July 29, 2008

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-signed informed consent
•\-age between 18 and 75 years
•\-primary diagnosis of histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or distal one third of the esophagus
•\-stage II or III, i.e. TNM\-stage of T3\-4, N0\-3, M0 or T2, N1\-3, M0 or T1, N2, M0 (according to the clinical stages uT3\-4 NX M0, uT1\-2N\+M0\)
•\-intended curative resection decided by an experienced surgeon
•\-Karnofsky\-index \>\= 70%
•\-in women of child\-bearing age: negative pregnancy blood test at screening, but no earlier than 72 hours before onset of chemotherapy
•\-adequate hematologic, liver and renal function: neutrophils \>\=1,5 x 10^9/L; platelets\>\= 100 x 10^9/L; hemoglobin \> 10 g/dl, calculated creatinin\-clearance (Cockroft\-Gault) \> 60ml/min; total bilirubine \<\= 1,0 x UNL, AST ALT \<\= 1,5 x UNL; AP \<\= 2,5 x UNL
•\-complete staging within 3 weeks before onset of chemotherapy (chest CT, abdomen CT, endosonoscopy, gastroscopy)
•\-ability to meet the deadlines and comply with protocol

•\-previous therapy of a carcinoma of the gastroesophageal junction (surgery, chemo\- or radiotherapy)
•\-diagnosis of a previous malignant disease in the 5 years preceding the study participation that was healed by more than surgical means (apart from carcinoma in situ of the cervix uteri and cured skin cancer other than melanoma)
•\-known deficiency of dihydropyrimidine\-dehydrogenase (DPD)
•\-known contraindication as to the chemotherapeutics applied in the trial
•\-existence of distant metastases
•\-known serious diseases or other concomitant diseases which could affect the participation, e.g.:
•\*unstable cardiac disease: symptomatic cardiac insufficiency, angina pectoris, ventricular arrhythmia in spite of medical treatment, myocardial infarction or cardiopulmonar resuscitation during 6 months preceding trial participation
•\*active infection requiring systemic therapy or uncontrolled infection
•\*interstitial lung disease (e.g. pneumonitis, fibrosis) or suspicion of interstitial lung disease in chest X\-ray or CT
•\*active inflammatory bowel disease or other bowel diseases causing chronic diarrhea (defined as more than 4 defecations per day)