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

Nowadays, the only curative option for localized gastric cancer is a curative
radical resection. Prognosis, however, remains poor. Results of the SWOG
9008/INT 0116 Phase III trial and the MAGIC trial have underlined the impetus
for (neo)adjuvant treatment strategies in combination with adequate
protocolized surgery in localized and/or locally advanced gastric cancer.
In advanced gastric cancer, a combination of docetaxel, cisplatin and 5-FU
(DCF) has been shown to be a very attractive option (TAX 325 and SAKK 42/99
studies). Furthermore, the use of an orally bioavailable fluoropyrimidine
(capecitabine) in combination with docetaxel and cisplatin would enable
patients to be treated without the requirement of an indwelling central venous
catheter.

This study investigates the feasibility role of neoadjuvant chemotherapy,
consisting of docetaxel (Taxotere), cisplatin and capecitabine (Xeloda) (TCX),
and protocolized surgery in localized and/or locally advanced resectable
gastric cancer (D1extra-resection). Furthermore, response measurement with CT
(PET-CT) will be evaluated.

Phase II prospective descriptive study in 50 patients. Experience toxicity is
documented. Quality of surgery is protocolized and guaranteed by consultant
surgeons of a surgical quality assurance committee.

Every patient included in this study will receive 4 courses of chemotherapy
consisting of Taxotere, Xeloda and Cisplatin

Patients are treated with 4 courses of chemotherapie. Before each cycle, a
venapunction will be carried out to assess if a patient can proceed to the next
cylce. On the first day of each cylce, a patient will be admitted to the
hospital for intravenous treatment with chemotherapy. Patients will undergo one
extra CT-scan to measure the respons of the tumor-load to chemotherapy.
Side-effects can exist of i.e. hairloss, febrile neutropenia, thrombocytopenia,
nausea, diarrhoea, hand-foot syndrome, neurotoxicity, skin problems
(irritation, rash). Surgery will be a burden for patients, but this is not
different from regular therapy for gastric cancer.
We are of the opinion that due to the poor 5-year survival of gastric carcinoma
resected with a curative intent there is a necessity for research for other
kinds of therapy which can improve survival.