A study to investigate the feasibility of chemotherapy prior to surgery and protocolized surgery in resectable stomach cancer.
Recruiting
- Conditions
- Resectable/curable gastric cancer
- Registration Number
- NL-OMON20157
- Lead Sponsor
- dr K. Bosscha, surgeondr J.F.M. Pruijt, oncologistdrs A.E. Dassen, resident in training for surgery
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma;
2. Siewert 2 and 3;
Exclusion Criteria
1. Inoperable patients;
2. Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Feasibility and toxicity/safety profile of the combination of 4 courses of docetaxel/Taxotere, cisplatin and capecitabine/Xeloda as neoadjuvant chemotherapy in resectable localized or locally advanced gastric cancer;<br /><br>2. Assessment of neoadjuvant chemotherapy-induced tumour response with CT or optional PET-CT;<br /><br>3. Implementation of a D1extra-resection implementation as protocolized surgery in resectable gastric cancer and rate of successful implementation;<br /><br>4. Assessment of quality of life after treatment with neo-adjuvant chemotherapy and surgery in local or locally advanced gastric carcinoma.
- Secondary Outcome Measures
Name Time Method 1. Determination of chemotherapy-induced pathological response according to WHO criteria for measurement of response;<br /><br>2. Determination of pathological resection (R0/R1/R2).