Status:
COMPLETED
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
Lead Sponsor:
Jeroen Bosch Ziekenhuis
Collaborating Sponsors:
Eindhoven Cancer Registry
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01517009
Start Date
June 1 2008
End Date
May 1 2013
Last Update
June 26 2013
Active Locations (5)
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1
VieCuri Hospital
Venlo, Limburg, Netherlands, 5912 BL
2
Jeroen Bosch Hospital
's-Hertogenbosch, North Brabant, Netherlands, 5200 ME
3
Catharina Hospital
Eindhoven, North Brabant, Netherlands, 5602 ZA
4
Elkerliek Hospital
Helmond, North Brabant, Netherlands, 5700 AB