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

Phase 2

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT01517009
• Lead Sponsor: Jeroen Bosch Ziekenhuis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-25
• Primary Completion: 2012-11
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer	30 days

Trial Locations

Locations (5)

VieCuri Hospital; 🇳🇱 Venlo, Limburg, Netherlands

Jeroen Bosch Hospital; 🇳🇱 Den Bosch, Noord-Brabant, Netherlands

Elkerliek Hospital; 🇳🇱 Helmond, Noord Brabant, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

Maxima Medical Centre; 🇳🇱 Veldhoven, Noord-Brabant, Netherlands