Gastric carcinoma stadium Ib-IVa MedDRA version: 9.1 Level: LLT Classification code 10017770 Term: Gastric carcinoma MedDRA version: 9.1 Level: LLT Classification code 10008452 Term: Chemotherapy multiple agents systemic
Conditions
Interventions
Trade Name: Taxotere
Product Name: Taxotere
Pharmaceutical Form: Intravenous infusion
CAS Number: 114977-28-5
Other descriptive name: DOCETAXEL
Trade Name: Xeloda
Product Name: Xeloda
Pharmaceutical
Sponsors
Jeroen Bosch Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ib-IVa histological proven resectable gastric adenocarcinoma WHO or = 18 years No prior radio- or chemotherapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Ia gastric cancer Other histological type than adenocarcinoma Distant metastases Inoperable patients Other current serious illness or medical conditions Known hypersensitivity to Docetaxel/Taxotere Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the feasibility and toxicity of the combination of 4 courses of docetaxel/Taxotere?, cisplatin and capecitabine/Xeloda? as neoadjuvant chemotherapy in resectable localized or locally advanced gastric cancer Percentage of patients who completed 4 courses of chemotherapy and proceeded to surgery Surgical quality control in resectable gastric cancer Establishment of toxicity and safety profile Assessment of the reduction of tumour load with CT (or PET-CT) after neoadjuvant chemotherapy ;Secondary Objective: Introduction of a D1extra-resection as the standard surgical treatment Percentage of complete pathological response Percentage of complete pathological resection (R0/R1/R2) Assessment of quality of life after treatment with neo-adjuvant chemotherapy and surgery in local or locally advanced gastric carcinoma ;Primary end point(s): response rate by CT (or optional PET-CT), percentage of operable patients, surgical and pathological results, toxicity, and quality of life | — |
Countries
Netherlands
Outcome results
None listed