Neoadjuvant chemotherapy in patients with locally advanced and /or nodal positive gastric cancer with Docetaxel, Cisplatin and 5-FU

ISRCTN	ISRCTN43859589
DOI	https://doi.org/10.1186/ISRCTN43859589
Secondary identifying numbers	23:07:2007

Submission date: 27/07/2011
Registration date: 18/10/2011
Last edited: 16/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Julia Mayerle
Scientific

Medical University of Greifswald
Department of Internal Medicine
Friedrich-Loeffler-Straße 23a
Greifswald
17475
Germany

Study information

Study design	Non-randomised open-label single-group interventional single-centre trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	http://www.medizin.uni-greifswald.de/gastro/Studien/magen-ca.htm [German]
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
Study acronym	NeoDox
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	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 study start date	01/09/2007
Completion date	29/02/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	46
Key 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
Key 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
Date of first enrolment	01/09/2007
Date of final enrolment	29/02/2012

Locations

Countries of recruitment

Germany

Study participating centre

Medical University of Greifswald

Greifswald
17475
Germany

Sponsor information

Medical University of Greifswald (Germany)
University/education

Fleischmannstraße 8
Greifswald
17475
Germany

Website	http://www.medizin.uni-greifswald.de/
"ROR"	https://ror.org/00r1edq15

Funders

Funder type

University/education

Medical University of Greifswald (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

16/09/2016: Plain English summary added.