Clinical trial NCT01517009: A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
Official title: A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Neo-adjuvant chemotherapy
D1extra-resection
Lead sponsor: Jeroen Bosch Ziekenhuis
Sponsor class: OTHER
Collaborators: name: Eindhoven Cancer Registry
First posted: 2012-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 18 weeks
Secondary outcomes:
measure: The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer
timeFrame: 30 days
Other outcomes:
Locations:
city: Venlo
country: Netherlands
facility: VieCuri Hospital
state: Limburg
city: Helmond
country: Netherlands
facility: Elkerliek Hospital
state: Noord Brabant
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Hospital
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord-Brabant
city: Veldhoven
country: Netherlands
facility: Maxima Medical Centre
state: Noord-Brabant
Study officials:
References: