A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer An IKZ-based phase II feasibility study

Phase 2

Completed

Conditions: gastric cancer
gastric carcinoma
10017990
10017991
10017998

Registration Number: NL-OMON31603

Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma Siewert 2 and 3
WHO < or equal to 1
Age > or equal to 18 years
No prior radio- or chemotherapy conflicting with the treatment of gastric cancer

Exclusion Criteria

Ia gastric cancer
Other histological type than adenocarcinoma
Distant metastases
Inoperable patients
Previous or other current malignancies
Other current serious illness or medical conditions
Pregnant or lactating women

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Assessment of the feasibility and toxicity efficacy/response rate<br /><br>(down-sizing/down-staging) of the combination of 4 courses of<br /><br>docetaxel/Taxotere, cisplatin and capecitabine/Xeloda as neoadjuvant<br /><br>chemotherapy in resectable localized or locally advanced gastric cancer<br /><br>- Percentage of patients who completed 4 courses of chemotherapy and proceeded<br /><br>to surgery<br /><br>- Surgical quality control in resectable gastric cancer<br /><br>- Establishment of toxicity and safety profile<br /><br>- Assessment of the reduction of tumour load with CT (or PET-CT) after<br /><br>neoadjuvant chemotherapy</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Introduction of a D1extra-resection as the standard surgical treatment<br /><br><br /><br>- Percentage of complete pathological response<br /><br>- Percentage of complete pathological resection<br /><br>- Assessment of quality of life after treatment with neo-adjuvant chemotherapy<br /><br>and surgery in local or locally advanced gastric carcinoma</p><br>