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

NCT01517009 | Completed Phase 2 DMC

• 3 other identifiers: DoCCSDutch trialregister2007-007273-23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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

Keywords

Neo-adjuvant chemotherapy; D1extra-resection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer

  30 days

Interventions

Docetaxel DRUG

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

Also known as: Taxotere

cisplatin DRUG

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

Capecitabine DRUG

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

Also known as: Xeloda

D1extra-resection PROCEDURE

An extended lymphadenectomy compared to a D1 resection for gastric cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeroen Bosch Ziekenhuis: lead
• Eindhoven Cancer Registry: collaborator

Study Sites (5)

VieCuri Hospital

Venlo, Limburg, 5912 BL, Netherlands

Location

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, 5200 ME, Netherlands

Location

Catharina Hospital

Eindhoven, North Brabant, 5602 ZA, Netherlands

Location

Elkerliek Hospital

Helmond, North Brabant, 5700 AB, Netherlands

Location

Maxima Medical Centre

Veldhoven, North Brabant, 5500 MB, Netherlands

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Cisplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms A.E. Dassen, MD, Principle Investigator

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: January 25, 2012
• Study Start: June 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

NL (5)