Plain English Summary
Background and study aims
Gastric cancer is a fairly uncommon type of cancer that develops from the lining of the stomach. Cancer that begins in the stomach and spreads to another part of the body or comes back after treatment is termed advanced stomach cancer. Despite the use of aggressive chemotherapies (medicines that stop cancer cells from dividing and multiplying), the outlook for patients with advanced gastric cancer is rather poor. Even after radical surgery, the overall 5-year survival rate is 20 – 30 % in Europe. Chemotherapy can be given before surgery to try to shrink the tumour so it may then be easier to remove. This type of treatment is called neoadjuvant chemotherapy. The aim of this study is to assess the effectiveness and toxicity (side effects) of neoadjuvant chemotherapy with the drugs docetaxel, cisplatin and 5-FU.
Who can participate?
Patients aged 18 and older with advanced gastric cancer
What does the study involve?
Chemotherapy treatment is given in three cycles, which start on days 1, 22 and 43. For safety monitoring, blood samples are taken on a weekly basis, heart activity is monitored and side effects are recorded. Participants are assessed to see whether the cancer can be fully removed in surgery (curative resection). Side effects and quality of life are also assessed to measure the impact of the disease and chemotherapy on daily life.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Medical University of Greifswald (Germany)
When is the study starting and how long is it expected to run for?
September 2007 to February 2012
Who is funding the study?
Medical University of Greifswald (Germany)
Who is the main contact?
Prof. Julia Mayerle
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
23:07:2007
Study information
Scientific title
Phase II trial for neoadjuvant chemotherapy in patients with locally advanced and /or nodal positive gastric cancer (UICC stages IIIa, IIIb and IV M0) with Docetaxel, Cisplatin and 5-FU
Acronym
NeoDox
Study hypothesis
A neoadjuvant chemotherapy in patients with advanced gastric cancer is expected to improve R0 surgical resection and therefore prolong survival of these patients
Ethics approval
Ethics Committee at the Medical Faculty of the University of Greifswald [Ethikkommission an der Medizinischen Fakultät der Universität Greifswald], 26/02/2004, ref: III UV 10/04
Study design
Non-randomised open-label single-group interventional single-centre trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
http://www.medizin.uni-greifswald.de/gastro/Studien/magen-ca.htm [German]
Condition
Locally advanced and/or nodal positive gastric cancer (UICC Stages: IIIa, IIIb, IV M0)
Intervention
1. Docetaxel: 75 mg/m2, (infusion, days 1, 22, 43)
2. Cisplatin: 75 mg/m2, (infusion, days 1, 22, 43)
3. 5-FU: 750 mg/(m2 x day), (infusion, days 1-5, 22-26, 43-47)
Intervention type
Drug
Phase
Phase II
Drug names
Cisplatin, docetaxel, 5-FU
Primary outcome measure
Rate of curative (R0) resections after a neoadjuvant chemotherapy
Secondary outcome measures
1. Median survival
2. Median progression-free survival
3. Remission rate
4. Toxicity of the protocol
5. Quality of life during neoadjuvant chemotherapy
Overall trial start date
01/09/2007
Overall trial end date
29/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Locally advanced and/or node positive gastric adenocarcinoma (UICC stages IIIa, IIIb, IV and M0)
2. Aged 18 years and older
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0 - 2
4. Adequate organ function
5. Signed informed consent
6. Participants: patients of both genders, no healthy volunteers
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant exclusion criteria
1. Metastatic disease
2. Prior chemotherapy for gastric cancer
3. Tumour recurrence after gastrectomy
4. Estimated life expectancy < 3 months
5. Presence of any serious concomitant systemic disorder
Recruitment start date
01/09/2007
Recruitment end date
29/02/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Medical University of Greifswald
Greifswald
17475
Germany
Sponsor information
Organisation
Medical University of Greifswald (Germany)
Sponsor details
Fleischmannstraße 8
Greifswald
17475
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Medical University of Greifswald (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list