A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore, an extended type of removal of lymph nodes will be implemented.

Official Title
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A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: cisplatin
* Drug: Capecitabine
* Procedure: D1extra-resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma Siewert 2 and 3 ASA 2 or less Age 18 years or more No prior radio- or chemotherapy conflicting with the treatment of gastric cancer Haematology/Renal function/Liver function within designated range Patient's consent form obtained, signed and dated before beginning specific protocol procedures absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial before patient registration/randomization, written informed consent must be given according to GCP, WMO and local regulations. Exclusion Criteria: Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer Other current serious illness or medical conditions Severe cardiac illness (NYHA class III-IV) Significant neurologic or psychiatric disorders Uncontrolled infections Active DIC Other serious underlying medical conditions that could impair the ability of the patient to participate in the study Known hypersensitivity to docetaxel (or any drug formulated with Polysorbate-80), or cisplatin or capecitabine or 5-FU Definite contraindications for the use of corticosteroids Use of immunosuppressive or antiviral drugs Any other experimental drugs within a 4-week period prior to start of neoadjuvant chemotherapy and throughout the study period Pregnant or lactating women Patients with reproductive potential not implementing adequate contraceptive measures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Docetaxel|60 mg/m2, 1 gift every 3 weeks, in total 4 gifts|
|Drug: cisplatin|60 mg/m2, one gift every three weeks, in total 4 gift|
|Drug: Capecitabine|1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles|
|Procedure: D1extra-resection|An extended lymphadenectomy compared to a D1 resection for gastric cancer|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with (serious) adverse events receiving the combination of 4 courses of docetaxel, cisplatin and capecitabine as neoadjuvant chemotherapy and standardized surgery in resectable localized or locally advanced gastric cancer. | Patients receive every 3 weeks a cycle of chemotherapy, in total 4 cylcles will be given. Surgery will be performed approximately 6 weeks after the last cycle. | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neo-adjuvant chemotherapy, D1extra-resection