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

Gastric Cancer Clinical Trial

— DoCCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517009
• Other study ID #: DoCCS
• Secondary ID: Dutch trialregis
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2011
• Last updated: June 25, 2013
• Start date: June 2008
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Jeroen Bosch Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: METOPP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Docetaxel
60 mg/m2, 1 gift every 3 weeks, in total 4 gifts
• cisplatin
60 mg/m2, one gift every three weeks, in total 4 gift
• Capecitabine
1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles

Procedure:
• D1extra-resection
An extended lymphadenectomy compared to a D1 resection for gastric cancer

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Hospital	Den Bosch	Noord-Brabant
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant
Netherlands	Elkerliek Hospital	Helmond	Noord Brabant
Netherlands	Maxima Medical Centre	Veldhoven	Noord-Brabant
Netherlands	VieCuri Hospital	Venlo	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Jeroen Bosch Ziekenhuis	Eindhoven Cancer Registry

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	18 weeks	Yes
Secondary	The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer		30 days	Yes