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

NCT ID: NCT01517009

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-05-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Docetaxel

60 mg/m2, 1 gift every 3 weeks, in total 4 gifts

Intervention Type: DRUG

cisplatin

60 mg/m2, one gift every three weeks, in total 4 gift

Intervention Type: DRUG

Capecitabine

1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles

Intervention Type: DRUG

D1extra-resection

An extended lymphadenectomy compared to a D1 resection for gastric cancer

Intervention Type: PROCEDURE

Other Intervention Names

Taxotere; Xeloda

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eindhoven Cancer Registry

OTHER

Sponsor Role: collaborator

Jeroen Bosch Ziekenhuis

OTHER

Sponsor Role: lead

Responsible Party

Anneriet Dassen

Ms A.E. Dassen, MD, Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VieCuri Hospital

Venlo, Limburg, Netherlands

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, Netherlands

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Elkerliek Hospital

Helmond, North Brabant, Netherlands

Maxima Medical Centre

Veldhoven, North Brabant, Netherlands

Countries

Netherlands

Other Identifiers

Dutch trialregister

Identifier Type: REGISTRY

Identifier Source: secondary_id

2007-007273-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DoCCS

Identifier Type: -

Identifier Source: org_study_id