Gastric Cancer
Conditions
Keywords
Neo-adjuvant chemotherapy, D1extra-resection
Brief summary
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.
Interventions
DRUGDocetaxel
60 mg/m2, 1 gift every 3 weeks, in total 4 gifts
DRUGcisplatin
60 mg/m2, one gift every three weeks, in total 4 gift
DRUGCapecitabine
1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles
PROCEDURED1extra-resection
An extended lymphadenectomy compared to a D1 resection for gastric cancer
Sponsors
Eindhoven Cancer Registry
Jeroen Bosch Ziekenhuis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 18 weeks | 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. |
Secondary
| Measure | Time frame |
|---|---|
| The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer | 30 days |
Countries
Netherlands
Outcome results
None listed